Pharmaceutical Industrial Training Report

lOMoAR cPSD| 15737326
INDUSTRIAL TRAINING REPORT

A Report submitted in partial fulfillment of the requirement for the degree of
BACHELOR OF PHARMACY
MORADABAD COLLEGE OF PHARMACY MORADABAD
SUBMITTED BY:
Rajat Rastogi
ROLL NO-1910460500035
Under the guidance of
Ms. Neha Gupta Dr. Subhranshu Panda

Assistant Professor Director
DR. APJ ABDUL KALAM TECHNICAL UNIVERSITY, LUCKNOW

UTTAR PRADESH
(SESSION 2021-22)
MIT College of Pharmacy , Moradabad
CERTIFICATE
This is to certify that the Report work entitled 'Industrial Training' has been
successfully carried out by Rajat Rastogi at the MIT COLLEGE OF
PHARMACY , Moradabad under the guidance of Neha Gupta (Assistant
Professor), Mit College of Pharmacy, Moradabad
Dr. Subhranshu Panda

Director
MIT College of Pharmacy
Moradabad
MIT College Of Pharmacy , Moradabad
CERTIFICATE
This is to certify that RAJAT RASTOGI Roll No. 1910460500035 has

carried out the report work entitled “Industrial Training” for the award of
degree of Bachelor of Pharmacy from Dr. APJ. Abdul Kalama Technical
University, Lucknow under my supervision.
Ms. Neha Gupta
Assistant Professor
moradabad institute of technology
College of Pharmacy
Moradabad
Date:
MIT College of Pharmacy, Moradabad
DECLARATION
I hereby declare that the Report work entitled “Industrial Training”

Submitted to Dr. APJ. Abdul Kalam Technical University, Lucknow for
the award of Degree of Bachelor of Pharmacy has been Successfully
carried out under the guidance of Neha Gupta (Assistant Professor)
MIT College of Pharmacy, Moradabad
RAJAT RASTOGI
Date:
ACKNOWLEDGEMENT
I would like to express my sincere and deep sense of gratitude, veneration I and
indebtedness to Dr. Subhranshu Panda Director, MIT College of Pharmacy, Moradabad,
for his constant encouragement and for providing me all type of necessary help during my
report work.
I would like to express my sincere and deep senses of gratitude to my esteemed guide Neha
Gupta (Assistant Professor) MIT College of Pharmacy, Moradabad, for her unstained
guidance, suggestions, constant encouragement, and optimization towards problems are
highly admirable. It is my proud privilege to have carried out this report work under his
guidance.
I also take this great opportunity to express my sincere thanks you all teaching and non-
teaching staff of MIT College of Pharmacy, Moradabad for their elderly help and
suggestions during my report work.
I express my deepest and very special thanks to my all-batch mates for their kind co-
operation, help and encouragement during my report work.
Finally, express my deep regards to God and My Parents, who have been a constant
source of inspiration.
… RAJAT RASTOGI
RAJAT RASTOGI Page 5

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PREFACE
Pharmacy is a profession which is concerned with the art and science of preparing
suitable and convenient material for distribution and use in the treatment and
prevention of disease, so it is fully technical profession where practical
knowledge is much more important along with theoretical knowledge.
According to curriculum of a four year integrated degree course of Bachelor of

Pharmacy each student has to undergo practical training for a period of four week
in a various pharmaceutical industry in India.
I was directed to undergo 4 weeks training at “Maxmed life sciences pvt ltd
rudrapur” and this report contains a brief description of the above
pharmaceutical industry which was observed during the training program.
Rajat Rastogi..

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INDUSTRIAL TRANING REPORT
TABLE OF CONTENTS
S.No. Topic Page No.

1. Industrial Training Certificate 8
2. Profile of Organization 9
3. Sections in Maxmed 10
4. Raw Material Store 11
5. Tablet Section 14
6. Capsule Section 22
7. Liquid Section 27
8. Parenteral Section 33
9. Quality Control and Quality Assurance Section 36
10. Microbiology Section 42
11. Finished Good Section 46
12. Good Manufacturing Practice 47
13. Standard operating procedure 52
14. Batch Production Record 54
15. Products associated with Maxmed Lifesciences Pvt Ltd 58
16. Conclusion 59

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1. INDUSTRIAL TRAINING CERTIFICATE

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2. PROFILE OF ORGANISATION
Maxmed life sciences pvt ltd

Plot no. 54/55, Sector – II dc Sidcul, Rudrapur
263153, Uttarakhand , India
 Maxmed Life Science Pvt. Ltd. is a company, established in 14 june 2004 , that promises good
health for all by providing quality medicines at affordable prices and committed to care the
people for keeping good health.
 They have won many accolades in the domestic and international pharmaceutical domain.
 They are engaged in manufacturing of pharmaceutical products for acute care market, etc.
 They are a leading group of companies that is headed by an experienced management involved in
the diverse field of pharma industry and is situated at the Uttrakhand which is conducive for a
pharma industry to grow.
 Their commitment towards quality, rich industry experience together with ethical business values
have taken us a long way in gaining a global recognition.
 They possess an image of a widely recognized manufacturer of injectable, latest tunnel system
for dry and liquid injectable, , dry syrups, tablets, capsules. .
 It is classified as Non-govt company and is registered at Registrar of Companies, Delhi. Its

authorized share capital is Rs. 50,000,000 and its paid up capital is Rs. 25,000,000. It is inolved
in Manufacture of other chemical products
 Maxmed Life Sciences Private Limited's Annual General Meeting (AGM) was last held on 30
November 2021 and as per records from Ministry of Corporate Affairs (MCA), its balance sheet
was last filed on 31 March 2022
 Directors of Maxmed Life Sciences Private Limited are Shubham Wasan, Sanjeev Wasan
 Maxmed Life Sciences Private Limited's Corporate Identification Number is (CIN)

U24232DL2004PTC126912 and its registration number is 126912.Its Email address is
[email protected] and its registered address is Plot no. 54/55, Sector – II dc
Sidcul, Rudrapur ,263153, Uttarakhand , India. Main branch situated at B-10, BASEMENT,
SHANKER GARDEN, VIKAS PURI NEW DELHI DL 110018 IN
MISSION
 .We will discover, develop, successfully marketed pharmaceutical products to prevent, diagnose,
alleviate and cure diseases.
RAJAT RASATOGI Page 9
Roll No -1910460500035
 We shall provide total customer satisfaction and achieve leadership in chosen market product,
and services across the glove through excellence in technology based on world class research
and development .
 We are responsible to the society. We shall be good corporate citizen and we will be driven by
a ethical standards in our practices.
VISION
 Our vision is to be leading pharmaceutical company in india and to become a significant global
player by providing high quality, affordable and innovative solution in medicine and treatment.
SOCIAL RESPONSIBILITY
At Maxmed , we believe that contributing back to the society is not only a

RESPONSIBILITY but a COMMITMENT. Our little value added to the betterment of society is a
part of our mission, in line with our commitment to human health. Through the years, Maxmed has
strived to make the world around it a better place. Corporate Social Responsibility (CSR) is not just
an integral part of our business but devotion; the promise of a brighter future for every life we touch
.
We consider it our duty to contribute a share of our earnings towards health benefits to the less
privileged, rural welfare to make life easier for rural poor and several charitable activities to do our
part towards the welfare of society as a whole.
3. SECTIONS IN MAXMED
 Raw Material Store

 Tablet Manufacturing Section
 Capsule Manufacturing Section
 Liquid Manufacturing Section
 Injections Manufacturing Section
 Quality Control and Quality Assurance Section
 Microbiology Section
 Finished Goods Section
 Engineering Section
RAJTA RASTOGI Page 10

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4. RAW MATERIAL STORE

A raw material also known as a feedstock or most correctly unprocessed material, is a basic
material that is used to produce goods, finished products, energy or intermediate materials which are
feedstock for future finished products. As feedstock, the term connotes these materials are bottleneck
assets and are highly important with regards to producing other products.
Pharmaceutical raw materials comprise substrates or elements that are used for
manufacturing different types of drugs e.g. endocrine disorder drugs, musculoskeletal system drugs,
anti-infective drugs viz. cephalexin, penicillin, ampicillin, cephradine, etc. Pharmaceutical excipients
and ingredients or raw materials used to manufacture drugs are extracted from different sources.
These sources could be natural or synthetic. Recently, many of the raw materials previously derived
from natural sources are being produced synthetically in part or even biotechnologically. This is so
because manufacturing them artificially is economical, safer and much quicker. Pharmaceutical raw
materials are manufactured using different types of acids, alcohols, esters, phenones, pyridines, etc.
Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include
active pharmaceutical ingredients (APIs) also known as bulk active are pharmaceutically active and
have desired pharmacological effects on the body e.g. alvimopan, sparfloxacin,
sapropterindihydrochloride, lanreotideacetate, nicotinic aicd, etc. In contrast pharmaceutical
excipients are the pharmaceutically inert substances which help in delivering the active ingredients
e.g. anti-adherents, binders, coatings, disintegrants, fillers, etc.
Fig.1 – Raw Material Store
STEPS INVOLVE IN RM STORE

 Receiving
 Sampling
 Storing
 Dispensing
Receiving
 Raw material is supplied by vendors by placing order.

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 After receiving the raw material check he “Observation on pack”.

 Segregate the raw material according to batch number.
 Pre entry cleaning of raw material by vacuum cleaner.
 Weighing of the raw material
Sampling
 Before sampling get line clearance by QA person.
 OC person test the sample of raw material under LAF by different tests and fill it in
“Observation on sampling are and pack” and “Certificate of analysis”.
 Warehouse operators will paste the labels of “Approved label” and “Sampled label”.
 Next sent raw material for storing.
Storing
 The raw material is stored at 3 different temperature zones –
o Ambient: Not more than 35 0C
o Controlled temperature room: 15 – 25 0C
o Cold room: 2 – 8 0C
Dispensing
 Raw material is picked for dispensing according to “Material pick list for process order” and
dispensed according to BMR prepared by QA personnel.
 Selection of raw material is done according to “First expiry first dispense”.
 Raw material is dispensed from dispensing booth under LAF to the production area.

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PRODUCTION SECTION
General Instructions and Precautions –
 Ensure area and equipment cleanliness before starting the manufacturing operations.
 Check and ensure that all manufacturing equipment and other required accessories are clean
ready for use.
 Wear gloves and nose mask during all manufacturing process.
 Counter check the weights of all ingredients before using in the batch.
 Get line clearance from QA for manufacturing.
 Air handling unit (AHU) system should be kept ON throughout the manufacturing process.
 Temperature should be kept between 25 0C + 2 0C and relative humidity should be kept between
50 + 10%.
 Ensure that QC approval purified water is being used for manufacturing purpose.
 Always transfer solution to the manufacturing vessels through 20 meshes.
 During the preparation of product, no other product processing should be done in the same area.
 Whenever sifting through SS mesh is involved; check the mesh integrity before and after use.
 All critical aspects during manufacturing like temperature, duration of mixing, weight, etc. must
be checked and recorded by the supervisor.
 Supervisor to ensure completion of all in-process records during various stages of manufacturing
operations till completion of the batch.
 Release from QA should be taken from all in-process tests mentioned in batch manufacturing
record.
 No over writing is allowed in batch manufacturing record. If initial data is wrong entered, cancel
the data by single stroke arrow and put initials. Record reasons for change as footnote on the
same page.
 All details whatever is necessary should be recorded in batch manufacturing record (BMR).
 Send a test request to QC after manufacturing is completed.
 Check all polyethylene bags before and after material loading for black particles and sealing.
 Check calibration of respective equipment/machine before use.

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5. TABLET MANUFACTURING SECTION

Tablet Components and Additives
A. Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, tranexemic acid,
azithromycin, cefixime, metformin, vitamin B6,etc.
B. Non-active Ingredients: six major excipient categories

a. Diluents: lactose, starch, mannitol, Sorbitol
b. Binders: Acacia, Gelatin, Tragacanth, starch.
c. Lubricants: stearic acid, magnesium stearate, calcium stearate. and talc
d. Disintegrants: Starches are the most common disintegrating agents
e. Colors: D&C and FD&C dyes and lakes, and
f. Flavors and Sweeteners: mannitol, lactose, sucrose, saccharin and dextrose.
Unit Operations
There are three methods of preparing tablet granulations. Such as:

(a) Wet granulation,
(b) Dry granulation (also called "slugging"), and
(c) Direct compression.
 Each of these methods has its advantages and disadvantages.

 Each individual operation of the process is known as a unit operation.
WET GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Preparation of binder solution.
4. Mixing binder solution with powder mixture to form wet mass.
5. Coarse screening of wet mass using 6- to 12- mesh.
6. Drying moist granules.
7. Screening dry granules with lubricant and disintegrants.
8. Mixing screened granules with lubricant and disintegrants.
9. Tablet compression.
DRY GRANULATION
2. Mixing of milled powders.
3. Compression into large, hard tablets called slugs.
4. Screening of slugs.
5. Mixing with lubricant and disintegrating agent.
DIRECT COMPRESSION

2. Mixing of ingredients.

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EQUIPMENTS
1. SIFTER
An instrument used to sieve the ingredients of a tablet with a replaceable mess ware. In this
technique, particles of power mass are placed on a screen made of uniform aperture. The sifter is
attached with a vibrator that helps in sieving the materials through the meshwork. The mechanism of
action is to loosen the packing of the particle in contact with screen surface, permitting entrapped sub
sieve particles to the screen surface.
Fig 2. Sifter Fig 3. Planetary Mixer
2. Planetary Mixer
For wet granulation a planetary mixer is used. Solutions of the binding agent are added to the mixed
powders with stirring. The powder mass is wetted with the binding solution until the mass has the
consistency of damp snow. The planetary mixer can mix a material of 100kg. The beater of the
planetary mixer revolves 2-4 times for each revolution of the head, providing double mixing action.
3. Mass Mixer
This is also mixing equipment used to mix dry as well is wet ingredients. The mixer has blades that
are alternately arranged and is allows uniform mixing. The mass mixer is emptied by inverting it and
scrapping off its ingredients. The planetary mixer can mix a material of 100kg.
4. Multi-mill
This is a hammer mill that uses a high speed rotor to which a number of swinging hammers are fixed.
The unit is enclosed with chamber containing a grid or removable screen through which the material
can pass. The material is fed from the top and ground by impact of hammers or against the plates
around the periphery of the casing. The materials are enough pass through the screen that forms the
lower portion of the chamber. The fragments are swept downward against the screen where they
undergo additional hammering action until they are reduced to a size small enough to pass through
the openings and out. Oversize particles are hurled upwards into the chamber where they also
undergo further blows by the revolving hammers.

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5. Fluidized bed dryer

In a fluidized bed dryer, the fluidized air stream is introduced by a fan or blower mounted at the top
of the apparatus. The air is heated to the required temperature in an air heater and flows upwards
through the wet materials, which remains in a drying chamber fitted with a wire mesh supported at
the bottom. By this process, the material is suspended and agitated in a warm air stream while the
granulation is maintained in motion.
Fig 4. Fluidized Bed Dryer Fig 5. Tray Dryer
6. Tray dryer
It consists of a chamber, containing horizontal arrangements of trays on which granules are dried.
The drying process is accomplished by a gust of hot air driven by or blower through an electric
heater and heat exchange. In this method, the wet materials are placed over paper sheets and finally
placed over the trays and the drying operation is carried out. These dryers are mainly useful for
materials that contain alcoholic solutions and where slow drying for better granule characteristic is
necessary.
7. Compressor
For increased production, Rotary machines offer a great advantage. A head carrying a number of sets
of punches and dies revolves continuously while the tablet granulation runs from the hopper, through
a feed frame and into the dies placed in a large, steel plate revolving under it. This method promotes
a uniform fill of the die and therefore an accurate weight for the tablet. Compression takes place as
the upper and the lower punches passes between a pair of rollers. This action produce a slow
squeezing effect on the material in the die cavity from the top and bottom and so gives a chance for
the entrapped air to escape. The punches and dies can be removed for inspection, cleaning and
inserting different sets to produce a great variety of shapes and sizes.

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TABLET PRESSES
 The basic unit of any tablet press is a set of tooling consisting of two punches and a die which is
called a station.
 The die determines the diameter or shape of the tablet; the punches, upper and lower, come
together in the die that contains the tablet formulation to form a tablet.
 There are two types of presses: single-punch and rotary punch.
 The single-punch press has a single station of one die and two punches, and is capable of
producing from 40 to 120 tablets per minute depending on the size of the tablet. It is largely used
in the early stages of tablet formulation development.
 The rotary press has a multiplicity of stations arranged on a rotating table in which the dies are
fed the formulation producing tablets at production rates of' from a few to many thousands per
minute.
 There are numerous models of presses manufactured by a number of companies, ranging in size,
speed, and capacity.
Tablet presses consist of

1) Hoppers, usually one or two, for storing and feeding the formulation to be pressed
2) Feed frame(s) for distributing the formulation to the dies
3) Dies for controlling the size and shape of the tablet
4) Punches for compacting the formulation into tablets
5) Cams (on rotary presses) that act as tracks to guide the moving punches. All other parts of the
press are designed to control the operation of the above parts.
Fig 6. Rotary Tablet Press

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COATING
 Tablet coatings perform one or more of the following functions. They may: mask the taste of
unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate
incompatible ingredients, control the release of medicament in the gastrointestinal tract, and
provide an elegant or distinctive finish to the tablet.
 The materials used for coating may largely comprise sucrose (sugar coating), water soluble film
forming polymers (film coating) or substances which are soluble in the intestinal secretions but
not in those of the stomach (enteric coating).
 These types of coating can all be applied by the pan or fluid-bed processes; the compression
coating technique is suitable for sugar and enteric coatings, but not for film coating.
TYPES OF COATING
1) SUGAR COATING
2) FILM COATING
3) MODIFIED RELEASE COATING
1) SUGAR COATING: This traditional coating imparts a smooth, rounded, elegant appearance to
the tablet. Stephenson and Smith (1951) have given a detailed discussion on the composition of
sugar coatings.
 The sugarcoating process involves building up layers of coating material on the tablet cores
as they are tumbled in a revolving pan by repetitively applying a coating solution or
suspension and drying off the solvent.
 Before sugarcoating, the core is coated with a sealing coat of shellac, PVP*-stabilized types
of shellac, or other polymeric materials, such as cellulose acetate phthalate and polyvinyl
acetate phthalate.
 The next stage is to build up a subcoat that will provide a good bridge between the main
coating and the sealed core, as well as round off any sharp corners. This step is followed by
smoothing or grossing.
 The finishing stage is accomplished by again applying one or two layers of clear syrup. The
tablets are then left for several hours before being transferred to the polishing pan.
 The polish is a dilute wax solution (e.g., carnauba or beeswax in petroleum spirit) applied
sparingly until a high luster is produced.
2) FILM COATING: Film coating has increased in popularity for various reasons.
 The film process is simpler and, therefore, easier to automate. It is also faster than
sugarcoating, since weight gains of only 2 to 6% are involved, as opposed to more than 50%
with sugarcoating.
 Two major groups of film coating materials may be distinguished:
(a) Those that are non-enteric and, for the most part, cellulose derivatives, and
(b) Those that can provide an enteric effect and are commonly esters of phthalic acid.
 Films may contain a plasticizer that prevents the film from becoming brittle with consequent
risk of chipping.
 Until recently, alcohols, esters, chlorinated hydrocarbons, and ketones have been among the
most frequently used types of solvents. However, because of increasing regulatory pressures
against undesirable solvents, there has been a pronounced trend toward aqueous film coating.
3) Modified-Release Coatings: A coating may be applied to a tablet to modify the release pattern of
the active ingredient.
 Two general categories, enteric coating and controlled-release coating, are distinguished.

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 The former are insoluble in the low pH environment of the stomach but dissolve readily in
the small intestine with its elevated pH.
 They are used to minimize irritation of the gastric mucosa by certain drugs and to protect
others that are degraded by gastric juices.
Fig 7. Tablet Coating Machine Fig 8. Automatic Coating Machine
PACKAGING AND LABELLING OF TABLETS
 Packaging and Labeling of tablets are done in Packaging and Labeling area.
 In this area concurrently three actions i.e. visual checking for contaminant or deformity, Labeling
and Packing are taking place.
 This room is fitted with air-conditioners and a temperature of about 27◦C is maintained.
 This area has an inspection table where deformity and contamination are checked against black
and white background.
 The minimum luminosity required in the inspection zone is 500lacs.
 The inspection table is fitted with stainless steel conveyors.
 The equipment is attached with a motor of 1 H.P. and a reduction gear box with adjustable
pulley.
 It is sometimes convenient to categorize packages by layer or functions –
1) Primary Packaging
2) Secondary Packaging
3) Tertiary Packaging
Primary Packaging – It is the material that first envelope the product and holds it. This usually is
the smallest unit of distribution or use and is the package which is in direct contact with the content.
Secondary Packaging – It is outside the primary packing and may be used to prevent pilferage or to
group primary packages together.

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Tertiary Packaging – These are used for bulk handling, warehouse storage and transport shipping.
The most common form of palletized unit load that packs tightly into containers.
Fig 9. Blister Packaging Machine
TYPES OF PACKAGING
1) BLISTER PACKING
2) STRIP PACKING
1) Blister Packing: This is useful for packaging of unit dose of pharmaceuticals. This packing mode
has been used extensively for several good reasons. It is a packaging configuration capable of
providing excellent environmental protection, coupled with an aesthetically pleasing and
efficacious appearance. It also provides user functionally in terms of convenience, child
resistance and now temperature resistance.
Blister packing consists of two principals components:-

1) A formed base web creating the cavity inside which the product fit.
2) The lidding foil for dispensing the product out of the pack.
2) Strip packing: The blister package is formed by heat softening a sheet of thermoplastic resin and
vacuum drawing the softened sheets of plastic into a contoured mould. After coming, the sheet
is released from the mould and proceeds to the filling station of the packaging machine. The
semi-rigid blister previously formed, is filled with the product and lidded with a heat sealable
backing material. The backing material can be either a push through or peelable type. For a push
through type of blister, the backing material is usually heat seal coated aluminum foil. The
packaging of the final product is done in paper cartons, manually, and is finally sealed using an
automatic sealer. The machine can seal cartons.

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Fig 10. Blister Packaging
Fig 11. Strip Packaging

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6. CAPSULE MANUFACTURING SECTION

 Capsule is the most versatile of all dosage forms.
 Capsules are solid dosage forms in which one or more medicinal and inert ingredients are
enclosed in a small shell or container usually made of gelatin.
 The process of manufacture of capsules is known as Encapsulation.
Types of Capsules
1) Hard Gelatin Capsule

2) Soft Gelatin Capsule
 The hard capsule is also called “two piece” as it consists of two pieces in the form of small
cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of
the longer piece, called the “body”.
 The soft gelatin capsule is also called as “one piece”. Capsules are available in many sizes to
provide dosing flexibility.
 Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell.
 The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.
INDUSTRIAL FILLING OF HARD GELATIN CAPSULES
a) Removal of caps
b) Filling of the bodies
c) Replacement of caps
d) Ejection of filled capsules
 Capsules are delivered into the perforated capsule filling ring.

 The ring is rotated on a turntable, and a vacuum pulls the bodies into the lower half of the ring,
leaving the caps in the upper half of the ring.
 The top & bottom halves of the filling ring are separated manually, and the cap half of the ring is
set aside.
 The body half of the ring is then moved to another turntable where it is rotated mechanically
under a powder hopper.
 The hopper contains an auger which feeds the powder into the bodies.
 When the capsule bodies are filled, the cap and body rings are rejoined.
FILLING OF POWDER IN CAPSULE SHELL

Filling of powder is generally done by the different machines. The equipments used for filling of
powder in capsule shell types –
1) Hand Operated Capsule Filling Machine.

2) Semi Automatic Capsule Filling Machine.
3) Automatic Capsule Filling Machine.
1) HAND OPERATED CAPSULE FILLING MACHINE

The machine is designed for filling a wide variety of formulation suitable for all classes of
pharmaceutical industry. The machine is simple to operate with no variation. The machine is fully
made out of stainless steel 304 quality except harden and lubricant parts.

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Fig 12. Hand Filling Capsule Machine
Features
 Low investment.
 Benefit ration simple to operate can be handled by UN skilled labor.
 All the loading plates are made of s.s.304 quality.
 Easily dismantle and reassembled even by unskilled labor.
Output
 8000 Capsule per/hour from 300 holes machine.
Working
 It consist of a bed having 200-300 hole, a loading tray having 200-300 holes, a power tray, a pin
plate having 200-300 pins, a sealing plate having a rubber top, a lever, a cam handle.
 The empty capsules are filled in the loading tray and it is placed over the bed.
 The cam handle is operated to separate the capsule caps form their bodies.
 The power tray is placed in a proper position and filled with an accurate quantity of power with
scraper.
 The excess of the powder is collected on the platform of the powder tray.
 The pin plate is lowered and the filled powder is pressed by moving the pin downwards.
 After pressing the pin plate is raised and the remaining powder is filled into the bodies of the
capsules.
 The powered tray is removed after its complete filling.
 The cap holding tray is again placed in position.
 The plate with the rubber top is lowered and the lever is operated to lock the caps and bodies.
 The loading tray is then removed and filled capsules are collected.
2) SEMI AUTOMATIC CAPSULE FILLING MACHINE

The Semi-Automatic Capsule filling machine is a user-friendly machine available with advanced
features.

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Fig 13. Semi Automatic Filling Capsule Machine
Features
 Fill weight accuracy
 Formulation yields
 Maintenance free operation
 Operator ease and safety
Innovative features
 Automation of loading station - This eliminates the need for continuous operator attention as
solid state control circuitry provides automatic stoppage of the loading table after completion of
one cycle, each of 60 strokes.
 Automation of filling station - This, again, is a revolutionary feature that eliminates the need for
continuous operator attention. Motorized. swing-in and swing-back of the drug hopper after one
filling cycle results in reduced operator fatigue.
 Pneumatic closing station - This utilizes an electronic sensor which activates a pneumatic
cylinder to carry out the closing operation resulting in ease of operation and reduced operator
fatigue.
 Vertical Closing - Vertical closing of filled capsules reduces reject rates and powder spillage.
This is critical for pellet filling. This is achieved by having two speeds for auger and nine speeds
for filling table operation.
 Modular type hopper provides easy and fast dismantling for cleaning. Change-over times
between batches are reduced.
 Filled capsule output capacity can be increased using our ring loading station. This allows
existing SA-9 installations to be upgraded for extra production.
Output
Capsule Size 00 0 1 to 5
No. of Holes/ Loading Ring 360 420 480
Output Per hour 21,600 25,200 48,960
With ring loading system 36,700 42,840 48,960
Output per hour

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3) AUTOMATIC CAPSULE FILLING MACHINE
 High Speed Automatic Capsule Filling machines are suitable for filling powders and pellets.
These are versatile machines with several outstanding features both functional and mechanical.
 The machines have capabilities to give an output of 40,000 capsules and 90,000 capsules per
hour with high filling accuracy and can accommodate capsule sizes.
 Capsule fillers are used to fill hard gelatin and non gelatin capsules with pre determined quantity
of liquids, powders, pellets, tablets.
 Most machines conform to the GMP guidelines with various safety features for maximum
operator protection.
 Capsules are normally fed into the machine, the filler then align, opens and accurately fills each
capsule and recloses.
 Fillers generate minimum dust with lowest level of product loss. Non-separated, double loaded
capsules and improperly inserted capsules are automatically rejected by machines to maintain the
consistency in the quality of product.
 Most capsule fillers are characterized with fast changeover time to accommodate a variety of
capsules in terms of shapes and size.
 High Quality Capsule Filling Machine requires minimal maintenance and easy to clean.
 Another important feature is the installation of speed adjusting equipment and automatic counters
ensuring the right quantity of capsules being filled and packed.
Fig 14. Automatic Filling Capsule Machine
Output
 Model - A 40 40,000 capsules per hour for powder & 30,000 capsules per hour for pellets.
 Model - A 90 90,000 capsules per hour for powder & 70,000 capsules per hour for pellets.

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POLISHING OF CAPSULE
CAPSULE POLISHING MACHINE
 This polishing machine is used after capsules were filled for cleaning the powder attached on the
capsules surface, through mechanically rotating brush and attraction of vacuum to take out the
external powder.
 As the chamber is made out of stainless steel is installing with filter cloth and nylon brush as an
the capsule are subjected to roll travel from one end of the brush to other end between nylon
bristles and filter cloth and the capsule get polish an get glossy finish.
 This part of the machine compatible with two stainless Steel chambers installed with filter cloth,
a revolving variable speed spiral nylon brush stainless Steel powder collector and a vacuum dust
collector.
 The capsules travel from one end to other end. During this travel they are subjected to roll in
between the nylon bristles and filter cloth.
 In this course the powder on the capsules and at the edge are removed and sucked by the dust
collector.
 In this process capsules are polished twice i.e. in two chambers the powder settled on the edge of
the capsules are also removed.
 The capsules coming out of the chute are thoroughly polished, shiny and clean.
Features
 Fill weight accuracy

 Formulation yields
 Maintenance free operation
 Operator ease and safety
Innovative features
 Feeding Machine - This section consists of a stainless steel hopper and a vibrator with powder
collector. As the capsules pass through the vibrator, some amount of powder gets collected in the
stainless steel collector.
 Inspection Machine - This part of the machine with a conveyor belt and vary speed drive.
Above this machine there is a lighting source to inspect the capsules minutely. The capsules
move on the conveyor belt and while moving they revolve around their axis due to angular
guides. This total visual inspection can be undertaken by an operator to sort out defective
capsules. The defective capsules are sorted manually by hand.

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7. LIQUID MANUFACTURING SECTION

 The Liquid Manufacturing Plants are ideal tools for the pharmaceutical industry for the
production of Oral Liquids.
 It is specially designed to take care of two critical factors which directly affect the quality of the
Liquids.
 Minimum manual handling of Liquid.
 Effective cleanness during manufacturing.
 It also provides the benefits of the effective manpower utilization.
LIQUID MANUFACTURING PLANT CONSIST THE FOLLOWING EQUIPMENTS AND

ACCESSORIES
 Sugar Syrup Vessel

 Manufacturing Vessel
 Storage Vessel
 Control Panel
 Product Piping
 Working Platform
SALIENT FEATURES OF THE LIQUID MANUFACTURING PLANT ARE AS FOLLOWS
 The Plant is designed to be operated only by one operator and one helper.
 All material transfers are done by vacuum or by transfer pumps.
 All the vessels are CGMP (paint free construction)
 The gaskets used are of silicon (food grade).
 All contact parts are of S.S. 304 quality material (SS316 provided on demand) & finished to class
4B (Mirror) finish and are crevice free.
 The entry of stirrer & high speed emulsifier are from top. In-line Emulsifier (as per customer
choice) provided on demand. (Optional)
 All vessels are suitable for internal pressure of 1 Kg. / Sq. cm. and hence can be sterilized.
 All pipes, pipe fittings and valves are of SS304 / SS316 (as per customer requirement) seamless
quality, internally electro polished, with triclover ended joints.
 The entire plant is equipped with CIP & SIP connections, so that customer can use this facility, if
have CIP & SIP equipment.
 All values of temperature & time of the plant are indicated digitally on the control panel. Ampere
indicates on Ampere meters.
 A micro processor based automatic operating plant can be designed as per requirement.
(Optional)
 All the inlet & outlet connections are provided with tri clover joints, which are very easy for
cleaning & replacement.
RAJAT RASTOGI Page- 27

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PROCESS CONTROL
 This system consists of a closed circuit manufacturing facility from feeding of Sugar / Water
Phase to loading the Volumetric Liquid Filling Machine.
 The Sugar and Water, are load with vacuum system or by mechanical system or manually.
 The Sugar Syrup Vessel is supplied with high speed stirrer & electrical heating (In small model) /
steam heating facility (In bigger size model).
 The sugar syrup is prepared at required temperature & is transferred to Manufacturing Vessel by
vacuum or by transfer pump.
 The product during emulsion formation is re-circulated through In-Line Homogenizer or Liquid
Transfer Pump.
 The Pump also discharges the product in the Storage Vessel.
 The Storage Vessel is then taken to the filling area (if it is small capacity) and is connected to
again Liquid Transfer Pump or Storage Vessel remains fixed (In bigger size) & pump transfer the
Liquids in the float tank which is connected with filling machine.
 The entire Plant can be operated by centralized operating panel by one operator.
 The plant is equipped with an electrical control panel with digital temperature indicators /
controllers and digital timers.
 Minimum two batches per shift of the same product can be assured in this plant.
 This plant conforms to CGMP standards (Paint Free Construction).
LIQUID FILLING MACHINES
1. AUTOMATIC LIQUID FILLING MACHINE
 Automatic anti-pressure liquid filling machine adopting the ways of vacuum filling to fill all
several of overflow products with high accuracy and versatility ensure filling without leakage, no
foam and damaged bottle is no incorporated.
 Automatic speed variation adjustment makes operation more convenient and reliable.
2. SEMI AUTOMATIC VOLUMETRIC LIQUID FILLING MACHINES
 Semi automatic volumetric liquid filling machines is two head, table top, fully GMP model used
to fill variety of liquids.
 Semi automatic volumetric liquid filling machine can be used for different types of glass, Plastic,
Metal containers.
 Semi automatic volumetric liquid filling machine works on volumetric principle and is fitted with
two syringes on the sides.
 The motor and gear box are covered in a SS cabinet. The desired volume can be adjusted by
increasing or decreasing the eccentricity. Bottles are kept bellow the nozzles manually.
 Output bottles per minute depending on type of liquid and fill size with the help of three speed
pulley arrangement.

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Fig 15. Semi Automatic Liquid Filling Machine
3. HIGH SPEED AUTOMATIC BOTTLE FILLING & CAP SEALING MACHINE
 High Speed Automatic Bottle Filling & Cap Sealing Machine can be adapted to a wide variety of
bottle shapes and liquids properties and can be used in various Industries such as
Pharmaceuticals, Cosmetics, Agrochemicals, Chemicals, Etc.
 This unit is fully automatic unit and can be coupled with a un-scrambler to feed the bottles to the
in feed conveyor of this machine.
 This machine achieves the complete operation of filling the bottles automatically and accurately.
 The complete filling sequence for different fill sizes is programmable for the speed with the
movement of a switch, achieves complete synchronization automatically.
 The fill range of this machine can be adjusted from 30 ml to 1000 ml with the change of syringes.
Higher fill volumes can be achieved by taking multiple strokes of the syringes.
 The number of filling head can be either 4, 6 or 8 depending upon the output required from this
unit. Usually we get an output of 80-160 bottles per minute. This also depends on the fill volume
of the bottle & number of filling heads.
 The filling machine is further attached to a manual capping machine which is to be operated by
an operator who would carry the bottle from the filling section, place the cap on the bottles neck
and seal it with the help of the rotating head.
 This operation is also done automatically by connecting an online automatic bottle capping
machine.
 The sealed bottles are then carried towards the inspection table by means of a slat conveyor,
where the bottles are visually inspected by the operator for any particles in the filled liquid.
 This process is simultaneously carried out in a white & black background and thereafter the
bottles are further transferred for next operation, i.e. labeling and packaging.
RAJAT RASTOGI Page-29

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ROTARY BOTTLE WASHING MACHINE
 The washing machines are ideal for washing injection bottles, infusion bottles, ampoules,
cartridges and syringes. It is designed to clean various types of glass bottles or plastic, metal
containers either round or odd shaped, subjecting it to a series of distinct processing operations.
 On washing machines, containers are fed individually and considerately through several stations:
flooding, washing (with or without ultrasonic support), blowing out and transfer to a downstream
sterilizing tunnel.
 The bottles are loaded on rotating platform where bottles are getting cleaned in a series of
operations. The bottles are placed in an inverted position in cups.
 The external cleaning of the bottles is done by spraying showers. Solenoid valves are provided to
enable the regulation of timings and sequence of various washing media to suit specific
requirement.
 Washing Sequences and positioning of washing stations can be interchanged as required for
liquid oral & injectable.
 Washing Machines are available with S.S. body, S.S stand and S.S. control panel as per the GMP
requirement.
 A vary speed drive pulley is provided for different output between 64 to 100 bottles per minute.
 Simple change over to different container sizes.
 Rotary Bottle washing machines are used for Bottle washing for pharmaceutical, food, cosmetic,
chemical etc.
 Bottle washing machines are suitable for different type and shape of bottle such as glass, plastic
and aluminum bottles.
4. ROPP CAP SEALING MACHINE
 ROPP CAP Sealing machine is ideal for continuous heavy duty operations.
 The machines are suitable to apply ROPP cap on round as well as flat, rectangular shaped bottles.
 The capping machines are ideal for application in pharmaceutical, liquor, food, agrochemical, edible
oil, lube oil and other packaging applications.
 Cap Sealing machines are equipped with hopper feeder for standard height of caps to feed the cap
on to the bottle neck for online capping.
 This machine is fully automatic and is complete with Rotary Cap Feeding Hopper and built-in
Slat Conveyor.
 The bottles are fed in a vertical position. As soon as the bottle strikes the end-chute, a cap from
the shoe of the automatic cap feeder is placed on the bottle and passed to the sealing head for
sealing.
 The sealing head seals the bottles and later conveys them to the slat conveyor for onward transfer
to inspection machine.
 The guide rails and stainless steel slat conveyor can be adjusted to accommodate various shapes
and diameter of bottles.
 A limit switch with actuator mechanism is provided for sensing bottle-topple.
 The machine is provided with variable speed mechanism for speed adjustment.

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5. SINGLE HEAD AUGER TYPE DRY SYRUP POWDER FILLING MACHINE
 Automatic Single Head Auger Type Dry Syrup Powder Filling Machine is a compact model used
for filling of Dry Syrup Powder into bottle.
 The incoming dry bottle (sterilized and siliconized) are fed through the infeed Turn Table with
suitably guided on the moving delrin flat conveyor belt at the required speed for feeding.
 Filling head is mounted on machine top plate.
 When bottle reaches to the filling station, it will be hold by the pneumatic bottle holder.
 Immediately it will be sensed by the bottle sensor as soon as it gets the signals from sensor
magnetic clutch starts to rotate which is mounted on auger shaft.
 It will fill the desire amount of powder to the bottle through auger, where rotation time is
previously saved in PLC control.
 After filling of bottle pneumatic piston goes back and releases the bottle to move on conveyor.
 The main advantage of this machine is Pneumatic bottle holding system is directly connected
with Auger rotation, so till bottle get filled with powder as per set value, pneumatic system will
not going to release the bottle.
6. DRY SYRUP POWDER FILLING MACHINE
 Automatic Monoblock Dry Syrup Powder Filling with Eight Head ROPP Cap Sealing Machine is
a Compact machine used for filling and sealing of Dry Syrup in bottles.
 The incoming dry container (sterilized and siliconised) are fed through the infeed Turn Table
with suitably guided on the moving delrin flat conveyor belt at the required speed for feeding to
the feed worm for correct spacing be two bottles and get enter into the infeed starwheel, which
will be transferred below funnel, 16 nos. of funnel is mounted on round plate and powder filling
head is mounted from centre pipe, which gives the flexibility to adjust power of wheel as per
requirement and consumes less space on machine.
 Machine will be having a lifter assembly on base of bottom plate, when bottle come below
funnel, bottom platform will lift the bottle and insert the bottle inside funnel.
 The sterilized powder is stored in to powder hopper is agitated by pair of mechanical agitators for
maintaining consistency and uniform bulk density, powder wheel rotates at the pre determined
speed below the powder hopper practically no clearance.
 Powder wheel consist of Piston in each port and behind the powder wheel vacuum plate is
provided there is no clearance between powder wheel and vacuum plate due to back spring
pressure.
 Volume of powder is sucked in to the port of powder wheel during vacuum according to the
piston length different fill size can be achieved.
 The excess powder is doctored off by a doctor blade, now doctor blades can be add from outside
also without removing powder hopper.
 When powder wheel indexes further and remain in the port due to the vacuum till it reaches just
vertical position.
 The time dose of Compressed air, sterilized low pressure Nitrogen Gas sequentially flushes out
powder from the port of powder wheel in to the funnel.

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 Funnel will be equipped with square rod to break the solid slug of powder and powder will start
to fill inside bottle, which is moving with funnel.
 In this model Bottle is getting around 5 to 6 second filling time.
 Bottles further move with funnel and reaches to exit star wheel, which is infeed star wheel for
eight head ROPP cap sealing machine, while rotating star wheel bottle picks up the cap from exit
end of chute, ROPP caps kept in orientation unit, automatically orient caps in right direction
before entering into delivery chute.
 And Bottle is entering below the sealing head, consist of four rollers. Two rollers properly Skirts,
Spins and Seals the cap and simultaneously another two roller performs perfect threading
according to bottle neck diameter.
 After sealing operation, sealing head moves upward with cam and bottle enters into exit star
wheel. Move further on conveyor belt for next operation.
RAJAT RASTOGI Page - 32

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08. PARENTERAL SECTION

 Parenteral preparations are sterile products those are administrated by injection into the body.
They may be directly administrated or they may be diluted before administration.
 Parenteral preparations are prepared by the methods that maintain their sterility, avoid the
introduction contaminants and microbial growth.
 The Parenteral preparations those are in the form of liquids require the base to dissolve them.
Water for Injection is commonly used in Parenteral preparations.
 Other auxiliary substances may be added to increase the stability and usefulness of the
preparation. Those substances at the added concentration they should not have any adverse effect
or cause toxicity. No coloring agent may be added to the Parenteral preparation for the purpose
of coloring.
 Parenteral preparations which are packaged in multiple-dose containers may contain suitable
antimicrobial preservatives in the appropriate concentration to inhibit the microbial growth in the
containers. The preservative effectiveness should be demonstrated before the production of
Parenteral preparation.
 When the active ingredients have the chances of oxidative degradation, a suitable antioxidant
may be added and/or the air in the container may be evacuated or displaced by nitrogen or other
suitable inert gas.
Containers
 Containers for Parenteral preparations should be made from materials that are transparent to
permit visual inspection of the contents of the containers and should not adversely affect the
quality of the preparation under the storage conditions, handling and use. These may be packed
in glass ampoules vials or bottles or in other containers such as plastic bottles.
Fig 18. Vials Filling with Rubber Stoppering, Capping & Labeling Machine
Closures
 Vials or bottles are closed with closures that are having a good seal to prevent the access of
micro-organisms and other contaminants and a part or the whole of the contents of the container
can be withdrawn without removal of the closure. The material of which the closure is composed
must be compatible with the preparation and must allow the passage of a needle with the minimal
shedding of particles and to ensure that the hole is resealed when the needle is removed.

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Fig 19. Ampoule Filling & Sealing Machine
Fig 20. Dry Injectable Powder Filling & Rubber Stoppering Machine
Inspection
 According to Good Manufacturing Practices, each final container of a Parenteral preparation
must be individually inspected for visible foreign material.
 If any foreign material is found, the container should be rejected.
Labeling
 The labeling of the containers of Parenteral preparations should be done in a manner that the area
should be uncovered to inspect the content of the container. The label of any Parenteral
preparation should contain the name of preparation, amount of active ingredient, storage
conditions and the amount of diluents to be used to get the specified concentration of the active
ingredient.

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Types of Parenteral Preparations

There are main following five types of Parenteral preparations:
1. Injections
2. Powders for Injection
3. Infusions
4. Concentrated Solutions for Injection
5. Implants
1. Injections
 Injections are sterile solutions those are prepared by dissolving the active ingredients and any
added substances in Water for Injection or in a suitable non-aqueous base, or in a mixture of
both if they are miscible.
 Injections that are suspensions may show sediment but should be readily dispersible on
shaking. The suspension should remain stable to deliver a homogenous dose of each
withdrawal from the container.
2. Infusions
 Infusions are sterile aqueous solutions with water as the continuous phase. They are free from
pyrogens or bacterial endotoxins, are usually made isotonic with blood and do not contain
any added antimicrobial preservatives.
3. Powders for injection
 Powders for injection are sterile solid substances those are distributed in their final volume
when shaken with the appropriate volume of sterile WFI to form a clear particle-free solution.
4. Concentrated Solutions for injection
 Concentrated Solutions for injection are sterile solutions that are administered by injection or
by intravenous infusion only after dilution with water for injection.
5. Implants
 Implants are sterile solid preparations of size and shape suitable for implantation into tissues
to release the active ingredient for a long time period. They are filled individually in sterile
containers.
Equipment Required
The following equipment's is recommended:
a) Manufacturing area
 Storage equipment for ampoules, vials bottles and closures.
 Washing and drying equipment.
 Dust proof storage cabinet
 Water still.
 Mixing and preparation tanks or other containers.
 Mixing equipment where necessary.
 Filtering equipment.
 Hot air sterilizer.
b) Aseptic filling and sealing rooms
 Benches for filling and sealing.
 Bacteriological filters.
 Filling and sealing unit under laminar flow work station.
c) General Room
 Inspection table.
 Leak testing table.
 Labeling and packing benches.
 Storage of equipment including cold storage and refrigerators if necessary.

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08. QUALITY CONTROL AND QUALITY ASSURANCE SECTION

Quality control is the part of GMP concerned with sampling, specification and testing and
with organization; documentation and release procedures which ensure that necessary and relevant
tests are carried out and that materials are not released for sale or supply, until their quality has been
judged satisfactory.
Quality Control (QC) laboratory ensures that the products are pure, safe and effective and are
released only after thorough analysis as per stringent specifications, methods and procedures
developed according to international guidelines viz. EU cGMP, MHRA, WHO, TGA, etc.
One of the most important elements in QC laboratory program is the quality and assurance of
the standard which are used. The standard can be broadly defined into two categories –
 Reference standard or primary standard
 Working standard or secondary standard
The working standard are those obtained from reliable source and whose purity and strength have
been optimized through test, generally compared with the reference standard. The quality control
section performs different control measure and test procedures to verify the product and material
quality. The tests are performed by the QC personnel and the results are matched with a reference
standard.
Different types of test are performed for different material. The types of test performed for each
material are as follows –
1. Size and Shape test
2. Color test
3. Hardness test
4. Friability test
5. Weight Variation test
6. Content uniformity test
7. Disintegration test
8. Dissolution test
9. HPLC
10. IR Spectroscopy
11. UV Spectrophotometer
1. Size and Shape – Thickness is + 5% of standard value control to facilitate packaging. Shaped
tablet requires slotted punches because of the non-uniformity force during compression.
2. Organoleptic Property – Color of product must be uniform. Non-uniformity of color on the

tablet is called Mottling.
3. Hardness
 Tablet requires a certain amount of strength or hardness and resistance to friability to withstand
mechanical shakes of handling in manufacture, packaging and shipping.
 Hardness generally measures the tablet crushing strength. The strength of a tablet was determined
by following ways;
(a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there
is a sharp snap, the tablet is an acceptable strength.

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(b) Tablet hardness can be defined as the force required breaking a tablet in a diametric
compression. In this test the tablet is placed between two anvils, force is applied to the
anvils, and the crushing strength that just causes the tablet to break is recorded.
 Generally used Hardness testers are:
a) Monsanto Tester
b) Strong-Cobb Tester
c) Pfizer Tester
d) Erweka Tester
e) Schleuniger Tester
 Hardness for compressed tablet is 5 to 8 kg.
Fig 21. Monsanto Tester Fig 22. Pfizer Tester
4. Friability
 Friability of a tablet can determine in laboratory by Roche friabilator.
 This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets through a Distance
of six inches in the friabilator, which is then operate for 100 revolutions.
 The tablets are reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh
are consider acceptable.
Fig 23. Roche Friabilator

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5. Weight Variation test (U.S.P.)

 Take 20 tablets and weighed individually.
 Calculate average weight and compare the individual tablet weight to the average.
 The tablet pass the U.S.P. test if no more that 2 tablets are outside the percentage limit and if no
tablet differs by more than 2 times the percentage limit.
6. Content Uniformity Test

 Randomly select 30 tablets. 10 of these assayed individually.
 The Tablet pass the test if 9 of the 10 tablets must contain not less than 85% and not more than
115% of the labeled drug content and the 10th tablet may not contain less than 75% and more than
125% of the labeled content.
 If these conditions are not met, remaining 20 tablets assayed individually and none may fall
outside of the 85 to 115% range.
7. Disintegration Test (U.S.P.)

 The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top and 10
mesh screens at the bottom end.
 To test for disintegration time, one tablet is placed in each tube and the basket rack is positioned
in a 1-L beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 2 0C such
that the tablet remain 2.5 cm below the surface of liquid on their upward movement and not
closer than 2.5 cm from the bottom of the beaker in their downward movement.
 Move the basket containing the tablets up and down through a distance of 5-6 cm at a frequency
of 28 to 32 cycles per minute.
 Floating of the tablets can be prevented by placing perforated plastic discs on each tablet.
 According to the test the tablet must disintegrate and all particles must pass through the 10 mesh
screen in the time specified. If any residue remains, it must have a soft mass.
 Disintegration time: Uncoated tablet: 5-30 minutes

 Coated tablet: 1-2 hours
Fig 24. Disintegration Test Apparatus Fig 25. Dissolution Test Apparatus

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8. Dissolution Test (U.S.P.)

 A single tablet is placed in a small wire mesh basket attached to the bottom of the shaft
connected to a variable speed motor.
 The basket is immersed in a dissolution medium (as specified in monograph) contained in a 100
ml flask.
 The flask is cylindrical with a hemispherical bottom.
 The flask is maintained at 37±0.5 0C by a constant temperature bath.
 The motor is adjusted to turn at the specified speed and sample of the fluid are withdrawn at
intervals to determine the amount of drug in solutions.
9. HPLC
 Most widely used separation technique
 Broad applicability – organic & inorganic
 Can be very sensitive, accurate & precise
 Suitable for separation of nonvolatile species
Chromatography can be described as a mass transfer process involving adsorption using a non-
polar stationary phase and a mobile polar phase titrating through the column. The active component
of the column, the sorbent or the stationary phase, is typically a granular material made of solid
particles (e.g. silica, polymers, etc.), 2-50 μm in size. High performance liquid chromatography
(HPLC) is a chromatographic technique used to separate a mixture of compounds in analytical
chemistry and biochemistry with the purpose of identifying, quantifying or purifying the individual
components of the mixture. Before the invention of HPLC, chemists had column chromatography at
their disposal, and column chromatography was time consuming. To speed up a classic column
chromatography, chemists would have to use a short column for separation, however this lead to
poor separation of molecular components held within solution. The basic setup of a classic column
chromatography would include the column that varied in I.D. from 10 to 50nm and column lengths
of 50-500cm. The column was then packed with the stationary phase ranging in particle size from
150 to 200 μm thick. Chemists realized that with the development of pressurized systems, reducing
the particle size would increase the efficiency. It was not until the late 60’s that chemists and
industrial engineering process acquired adequate technology and manufacturing techniques to
develop a smaller grained stationary phase that would be cohesive with a pressurized system.
Fig 26. HPLC

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10. FT-Infrared (IR) Spectroscopy

 It uses a beam of infrared light to analyze the structure of organic compounds. Whereas NMR
analyzes the atoms present, IR instead analyzes the bonds present. NMR produces a set of sharp
signals where every atom’s signal may be discerned, but IR only produces broad absorptions
which may frequently overlap. You are unlikely to be able to completely deduce a structure using
only IR. Nevertheless, IR provides a valuable tool for probing the structure of organic molecules.
 The infrared portion of the electromagnetic spectrum is divided into three regions; the near-mid-
and far-infrared, named for their relation to the visible spectrum. The far-infrared, approximately
400-10cm-1(1000–30μm), lying adjacent to the microwave region, has low energy and may be
used for rotational spectroscopy. The mid-infrared, approximately 4000-400cm-1(30–1.4μm)
may be used to study the fundamental vibrations and associated rotational vibrational structure.
The higher energy near-IR, approximately 14000-4000cm-1(1.4–0.8μm) can excite over tone or
harmonic vibrations. The names and classifications of these sub-regions are merely conventions.
They are neither strict division nor based on exact molecular or electromagnetic properties.
Fig 27. FT-IR
11. UV Spectrophotometer
 In Pharmaceutical Industry, A spectrophotometer is commonly used for the measurement of
transmittance or reflectance of solutions, transparent or opaque solids, such as polished glass.
 However they can also be designed to measure the diffusion any of the listed light ranges that
usually cover around 200nm-2500nm using different controls and calibrations. Within these
ranges of light, calibrations are needed on the machine using standards that very in type
depending on the wavelength of the photometric determination.
 The basic function of a spectrometer is to take in light, break it into its spectral components,
digitize the signal as a function of wavelength, and read it out and display it through a computer.
 The first step in this process is to direct light through a fiber optic cable into the spectrometer
through a narrow aperture known as an entrance slit. The slit vignettes the light assist enters the
spectrometer. In most spectrometers, the divergent light is then collimated by a concave mirror
and directed onto a grating.
 The grating then disperses the spectral components of the light at slightly varying angles, which
is then focused by a second concave mirror and imaged onto the detector. Alternatively, a

ROLL NO - 19100460500035
concave holographic grating can be used to perform all three of these functions simultaneously.
This alternative has various advantages and disadvantages, which will be discussed in more detail
later on.
 Once the light is imaged onto the detectors the photons are then converted into electrons which
are digitized and read out through a USB (or serial port) to a computer.
 The software then interpolates the signal based on the number of pixels in the detector and the
linear dispersion of the diffraction grating to create a calibration that enables the data to be
plotted as a function of wavelength over the given spectral range.
Fig 28 - UV Spectrophotometer

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10. MICROBIOLOGY SECTION

 The Guide to the Inspection of Pharmaceutical Quality Control Laboratories provided very
limited guidance on the matter of inspection of microbiological laboratories.
 While that guide addresses many of the issues associated with the chemical aspect of laboratory
analysis of pharmaceuticals, this document will serve as a guide to the inspection of the
microbiology analytical process.
 As with any laboratory inspection, it is recommended that an analyst (microbiologist) who is
familiar with the tests being inspected participate in these inspections.
Following processes are carried out in microbiology laboratory:

 Sterility Testing
 Antimicrobial Efficacy Testing (AFT)
 Microbial Limits Testing
 Bioburden Determination
 Endotoxin (LAL) Testing
 Environmental Monitoring and Identification
 Water Analysis
Microbiological Testing of Non-sterile Products

 For a variety of reasons, we have seen a number of problems associated with microbiological
contamination of topical drug products, nasal solutions and inhalation products.
 The USP Microbiological Attributes Chapter provides little specific guidance other than “The
significance of microorganisms in non-sterile pharmaceutical products should be evaluated in
terms of the use of the product, the nature of the product and the potential hazard to the user.”
 The USP recommends that certain categories be routinely tested for total counts and specified
indicator microbial contaminants. For example, natural plants, animals and some mineral
products for Salmonella, oral liquids for E.coli, topical for P.aeruginosa and S. aureus and
articles intended for rectal, urethral or vaginal administration for yeasts and molds. A number of
specific monographs also nclude definitive microbial limits.
 Microbiological testing may include an identification of colonies found during the Total Aerobic
Plate Count test. Again, the identification should not merely be limited to the USP indicator
organisms.
 The importance of identifying all isolates from either or both Total Plate Count testing and
enrichment testing will depend upon the product and its intended use.
 Obviously, if an oral solid dosage form such as a tablet is tested, it may be acceptable to identify
isolates when testing shows high levels. However, for other products such as topical, inhalants or
nasal solutions where there is a major concern for microbiological contamination, isolates from
plate counts as well as enrichment testing should be identified.
Sterility Testing
 One of the most important aspects of the inspection of a sterility analytical program is to review
records of initial positive sterility test results. Request list of test failures to facilitate review of
production and control records and investigation reports.
 Particularly for the high risk aseptically filled product, initial positive sterility test results and
investigations should be reviewed.
 It is difficult for the manufacturer to justify the release of a product filled aseptically that fails an
initial sterility test without identifying specific problems associated with the controls used for the
sterility test.

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 Examine the use of negative controls. They are particularly important to a high quality sterility
test. Good practice for such testing includes the use of known terminally sterilized or irradiated
samples as a system control.
 Alternatively, vials or ampoules filled during media fills have also been used. Be especially
concerned about the case where a manufacturer of aseptically filled products has never found an
initial positive sterility test. While such situations may occur, they are rare.
 In one case, a manufacturer’s records showed that they had never found positive results; their
records had been falsified. Also, the absence of initial positives may indicate that the test has not
been validated to demonstrate that there is no carryover of inhibition from the product or
preservative.
Validation
 Confirmation through the provision of objective evidence that the requirements for a specific
intended use or application have been fulfilled.
 Validation is one of the important steps in achieving and maintaining the quality of the final
product. If each step of production process is validated we can assure that the final product is of
the best quality.
 Validation of the individual steps of the processes is called the process validation. Different
dosage forms have different validation protocols.
Process Validation – It is establishing documented evidence which provides a high degree of

assurance that a specific process will consistently produce a product meeting its pre-determined
specifications and quality characteristics.
Types of Process Validation

 Prospective validation
 Retrospective validation
 Concurrent validation
 Revalidation
Instruments and Devices used in microbiology laboratory

 Analytical balance
 Incubator
 Refrigerator
 Laminar Air Flow/ Biosafety cabinet
 Magnetic stirrer
 Deep freezer
 Light microscope
 pH meter
 Autoclave
 Hot air oven
 Analytical Balance – They are used in precise weighting of small amounts of samples and
chemicals used for preparing media and stock solutions.
 Incubator – In the microbiology laboratories it is among the leading devices which are work at
different temperatures according to the purpose and the work load of the laboratory. It is used in
cultivating, multiplying and in the characterization tests of microorganisms. This device provides
the heat necessary for the growth of microorganisms.

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Fig 29. Incubator
 Biosafety Cabinet – It is used in microbial inoculation and isolation studies as well as sterile
storage of materials. In addition, it is utilized for protection of user, samples and the environment
from hazardous contamination.
 Refrigerator – The device is used for the storage of the stock solutions, chemicals, kits and
nutrient media that should be maintained at certain temperatures.
 Magnetic Stirrer – It is a device which provides mixing and keeping the chemical solutions and
mixtures at a certain time and temperature by the help of a magnetic bar. Vortex agitates the
solutions in the tube, flask and so on in certain speed and duration.
 Deep Freezer – It is used to store stock cultures in microbiology. It is a device used to store
materials which should be kept at low temperatures.
 Autoclave – The main purpose of this device is to sterilize materials and media under pressure
and steam.
Fig 30. Autoclave

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 Inverted Phase Contrast Light Microscope – By the help of different refractive properties of
the light, Phase Contrast Light Microscope provides visibility to sub-cellular structures of
microorganisms that are examined in a liquid medium without any staining. Fluorescence
attachment is used to display objects stained with special fluorescent dyes (DAPI, FITC, Texas
Red, etc.) and that cannot be displayed with normal light microscopy techniques. It operates
according to the principle of reflective light.
Fig 31. Light Microscope Fig 32. pH Meter
 pH Meter- It is used to determine the pH of the media prior to experiments and to monitor pH
value during experiments. The device is used especially in the preparation of stock solutions and
the culture media used for the growth of microorganisms.

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11. FINISHED GOODS SECTION

 Finished goods are goods that have completed the manufacturing process but have not yet been
sold or distributed to the end user.
 A good purchased as a “Raw material” goes into the manufacture of a product.
 A good only partially completed during the manufacturing process is called “work in process”.
 When the good is completed as to manufacturing but not yet sold or distributed to the end-user, it
is called a “finished good”. This is the last stage for the processing of goods.
 The goods are ready to be consumed or distributed.
 There is no processing required in term of the goods after this stage by the seller.
Procedure
 Receive the finished good transfer ticket from production duly authorized by production
supervisor and checked by QA.
 Following are to be made in finished good transfer ticket after received from production –
o Name of product
o Batch No.
o Manufacturing Date
o Expiry Date
o Quantity
o Date of transfer tickets
 Verify the received goods against transfer with above details.
 Ensure the all details are complete as per our requirements.
 In case of any observation, intimate to production department and get it corrected.
 Enter the physically verified quantity in SAP system.

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12. GOOD MANUFACTURING PRACTICE
Good manufacturing practices (GMP) are the practices required in order to conform
to the guidelines recommended by agencies that control authorization and licensing for
manufacture and sale of food, drug products, and active pharmaceutical products. These
guidelines provide minimum requirements that a pharmaceutical or a food product
manufacturer must meet to assure that the products are of high quality and do not pose any
risk to the consumer or public.
Quality Management
1. Principles:
a) Quality should be the responsibility of all persons involved in manufacturing.
b) Each manufacturer should establish, document, and implement an effective system for
managing quality that involves the active participation of management and appropriate
manufacturing personnel.
c) The system for managing quality should encompass the organization l structure, procedures,
processes and resources, as well as activities necessary to ensure confidence that the API will
meet its intended specifications for quality and purity.
d) All quality related activities should be defined and documented. There should be a quality
unit(s) that is independent of production and that fulfils both quality assurance (QA) and quality
control (QC) responsibilities.
e) This can be in the form of separate QA and QC units or a single individual or group,
depending upon the size and structure of the organization.
f) All quality related activities should be recorded at the time they are performed. Any deviation
from established procedures should be documented.
2. Responsibilities of the Quality Unit(s):

a) The quality unit(s) should be involved in all quality-related matters.
b) The quality unit(s) should review and approve all appropriate quality-related documents.
c) The main responsibilities of the independent quality unit(s) should not be delegated.
3. Product Quality Review:

Regular quality reviews of APIs should be conducted with the objective of verifying the
consistency of the process. Such reviews should normally be conducted and documented
annually and should include at least:
a) A review of critical in-process control and critical API test results.
b) A review of all batches that failed to meet established specification(s).
c) A review of all critical deviations or non-conformances and related investigations
d) A review of any changes carried out to the processes or analytical methods.
e) A review of results of the stability monitoring program
f) A review of all quality-related returns, complaints and recalls.
g) A review of adequacy of corrective actions. Personnel.

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1. Personnel Qualifications:
There should be an adequate number of personnel qualified by appropriate education, training
and/or experience to perform and supervise the manufacture of intermediates and APIs. The
responsibilities of all personnel engaged in the manufacture of intermediates and APIs should be specified
in writing. Training should be regularly conducted by qualified individuals and should cover, at minimum,
the particular operations that the employee performs and GMP as it relates to the employee's functions.
Records of training should be maintained. Training should be periodically assessed.
2. Personnel Hygiene:
Personnel should practice good sanitation and health habits. Personnel should wear clean clothing
suitable for the manufacturing activity with which they are involved and this clothing should be changed
when appropriate. Additional protective apparel, such as head, face, hand, and arm coverings, should be
worn when necessary, to protect intermediates and APIs from contamination. Personnel should avoid
direct contact with intermediates or APIs. Smoking, eating, drinking, chewing and the storage of food
should be restricted to certain designated areas separate from the manufacturing areas. Personnel suffering
from an infectious disease or having open lesions on the exposed surface of the body should not engage in
activities that could result in compromising the quality of APIs.
3. Consultants:
Consultants advising on the manufacture and control of intermediates or APIs should have
sufficient education, training, and experience, or any combination thereof, to advise on the subject for
which they are retained. Records should be maintained stating the name, address, qualifications, and type
of service provided by these consultants.
Buildings and Facilities:
1. Design and Construction

Buildings and facilities used in the manufacture of intermediates and APIs should be located,
designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the
type and stage of manufacture. Facilities should also be designed to minimize potential
contamination. Buildings and facilities should have adequate space for the orderly placement of
equipment and materials to prevent mix-ups and contamination. The flow of materials and
personnel through the building or facilities should be designed to prevent mix-ups or
contamination. Adequate, clean washing and toilet facilities should be provided for personnel.
These washing facilities should be equipped with hot and cold water as appropriate, soap or
detergent, air driers or single service towels. The washing and toilet facilities should be separate
from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or
changing clothes should be provided, when appropriate. Laboratory areas/operations should
normally be separated from production areas.

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2. Utilities:
All utilities that could impact on product quality (e.g. steam, gases, compressed air, and heating,
ventilation and air conditioning) should be qualified and appropriately monitored and action
should be taken when limits are exceeded. Adequate ventilation, air filtration and exhaust
systems should be provided, where appropriate. These systems should be designed and
constructed to minimise risks of contamination and cross-contamination and should include
equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and
temperature, as appropriate to the stage of manufacture. If air is recirculated to production areas,
appropriate measures should be taken to control risks of contamination and cross-contamination.
Pipework should be located to avoid risks of contamination of the intermediate or API. Drains
should be of adequate size and should be provided with an air break or a suitable device to
prevent back-siphonage, when appropriate.
3. Water:
Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use.
Where water used in the process is treated by the manufacturer to achieve a defined quality, the
treatment process should be validated and monitored with appropriate action limits. Where the
manufacturer of a non-sterile API either intends or claims that it is suitable for use in further
processing to produce a sterile drug (medicinal) product, water used in the final isolation and
purification steps should be monitored and controlled for total microbial counts, objectionable
organisms, and endotoxins.
Process Equipment:
1. Design and Construction:

Equipment used in the manufacture of intermediates and APIs should be of appropriate design
and adequate size, and suitably located for its intended use, cleaning, sanitization (where
appropriate), and maintenance. Production equipment should only be used within its qualified
operating range. Closed or contained equipment should be used whenever appropriate. Where
open equipment is used, or equipment is opened, appropriate precautions should be taken to
minimize the risk of contamination.
2. Equipment Maintenance and Cleaning:

Cleaning procedures should contain sufficient details to enable operators to clean each type of
equipment in a reproducible and effective manner. Equipment and utensils should be cleaned,
stored, and, where appropriate, sanitized or sterilized to prevent contamination or carry-over of a
material that would alter the quality of the intermediate or API beyond the official or other
established specifications.
These procedures should include:

a. Assignment of responsibility for cleaning of equipment.
b. Cleaning schedules, including, where appropriate, sanitizing schedules.

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c. A complete description of the methods and materials, including dilution of cleaning agents
used to clean equipment.
d. When appropriate, instructions for disassembling and reassembling each article of
equipment to ensure proper cleaning.
e. Instructions for the removal or obliteration of previous batch identification.
f. Instructions for the protection of clean equipment from contamination prior to use.
g. Inspection of equipment for cleanliness immediately before use, if practical.
h. Establishing the maximum time that may elapse between the completion of processing and
equipment cleaning, when appropriate.
3. Computerized Systems:
GMP related computerized systems should be validated. Commercially available software
that has been qualified does not require the same level f testing, Computerized systems
should have sufficient controls to prevent unauthorized access or changes to data. There
should be a record of any data change made, the previous entry, who made the change, and
when the change was made. Changes to the computerized system should be made according
to a change procedure and should be formally authorized, documented and tested. Records
should be kept of all changes, including modifications and enhancements made to the
hardware, software and any other critical component of the system.
Documentation and Records:
1. Documentation System:
All documents related to the manufacture of intermediates or APIs should be prepared,
reviewed, approved and distributed according to written procedures. Such documents can be in
paper or electronic form. When entries are made in records, these should be made indelibly in
spaces provided for such entries, directly after performing the activities, and should identify
the person making the entry.
2. Records of Raw Materials, Intermediates, API Labelling and Packaging Materials:
Records should be maintained including:
a) The name of the manufacturer, identity and quantity of each shipment of each batch of raw
materials, intermediates or labelling and packaging materials for API's; the name of the
supplier; the supplier's control number(s), if known, or other identification number; the
number allocated on receipt; and the date of receipt.
b) Records tracing the use of materials.
c) Documentation of the examination and review of API labelling and packaging materials for
conformity with established specifications.

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3. Master Production Instructions (Master Production and Control Records):
To ensure uniformity from batch to batch, master production instructions for each intermediate
and API should be prepared, dated, and signed by one person and independently checked, dated,
and signed by a person in the quality unit(s).
Master production instructions should include:

a) The name of the intermediate or API being manufactured and an identifying document
reference code, if applicable.
b) A complete list of raw materials and intermediates designated by names or codes sufficiently
specific to identify any special quality characteristics.
c) The production location and major production equipment to be used.
d) Detailed production instructions, including the The instructions for storage of the
intermediate or API to assure its suitability for use, including the labelling and packaging
materials and special storage conditions with time limits, where appropriate
4. Laboratory Control Records:
Laboratory control records should include complete data derived from all including
examinations and assays, as follows:
a) A description of samples received for testing, including the material name or source, batch
number or other distinctive code, date sample was taken, and, where appropriate, the quantity
and date the sample was received for testing.
b) A statement of or reference to each test method used.
c) A statement of the weight or measure of sample used for each test as described by the method.
d) A complete record of all raw data generated during each test, in addition to graphs, charts, and
spectra from laboratory instrumentation, properly identified to show the specific material and
batch tested.
e) The signature of the person who performed each test and the date(s) the tests were Performed.
f) The date and signature of a second person showing that the original records have been
reviewed for accuracy, completeness, and compliance with established standards.
Validation:
 Validation Policy:
The company's overall policy, intentions, and approach to validation, including the validation of
production processes, cleaning procedures, analytical methods, in process control test
procedures, computerized systems, and persons responsible for design, review, approval and
documentation of each validation phase, should be documented. The critical
parameters/attributes includes:
a) Defining the API in terms of its critical product attributes.
b) Identifying process parameters that could affect the critical quality attributes of the API
c) Determining the range for each critical process parameter expected to be used during
routine manufacturing and process control.
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13. STANDARD OPERATING PROCEDURES
A standard operating procedure, or SOP, is a set of step-by-step instructions created by a

business to help workers carry out routine operations. Their purpose is to achieve efficiency.
quality output and uniformity of performance, while reducing miscommunication and
failure to comply to industry regulations.
A Standard Operating Procedure (SOP) is a set of written instructions that document a

routine or repetitive activity which is followed by employees in an organization. The
development and use of SOPs are an integral part of a successful quality system. It provides
information to perform a job properly, and consistently in order to achieve pre-determined
specification and quality end-result.
Need Of Sop:
SOPs detail the regularly recurring work processes that are to be conducted or followed
within an organization. They document the way activities are to be performed to facilitate
consistent conformance to technical and quality system requirements and to support data quality.
They may describe, for example, fundamental programmatic actions and technical actions such as
analytical processes, and processes for maintaining, calibrating, and using equipment. Sops are
intended to be specific to the organization or facility whose activities are described and assist
that organization to maintain their quality control and quality assurance processes and ensure
compliance with governmental regulations.
Benefits Of Sop:
1. To provide people with all the safety, health, environmental and operational information necessary
to perform a job properly.
2. To ensure that production operations are performed consistently to maintain quality control of
processes and products.
3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule.
4. To ensure that no failures occur in manufacturing and other processes that would harm anyone in
the surrounding community,
5. To ensure that approved procedures are followed in compliance with company and government
regulations.
6. To serve as a training document for teaching users about the process for which the SOP was
written.
7. To serve as a checklist for co-workers who observe job performance to reinforce proper
performance.
8. To serve as an historical record of the how, why and when of steps in an existing process so there is
a factual basis for revising those steps when a process or equipment are changed.

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Writing Styles:
SOPs shall be written in a concise, step by step, easy to read and follow format. The information
presented should be unambiguous and not complicated. The active voice and present verb tense
should be used. SOP shall be simple and short. Information should be conveyed clearly and explicitly
to remove any doubt as to what is required. Flow chart shall be used to illustrate the process being
described.
Sop Preparation:
The organization should have a procedure in place for determining what procedures or
processes need to be documented. Those SOPs should then be written by individuals
knowledgeable with the activity and the organization's internal structure. These individuals
are essentially subject-matter experts who actually perform the work or use the process. A
team approach can be followed for better results.
Management of Sop:
Organization shall have SOP on Preparation, approval, revision and control of standard Operating
Procedure for better control and management of SOPs. Generally, administrative aspects of the
SOP system such as distribution and filing are well managed. On the other hand, overall system
management, frequently characterized by the lack of a system owner, is generally poor. If a system
owner exists at all, his or her responsibilities are limited. Ideally a system owner.

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14. BATCH PRODUCTION RECORDS
Batch production records should be prepared for each intermediate and API and should
include complete information relating to the production and control of each batch. The batch
production record should be checked before issuance to assure that it is the correct version
and a legible accurate reproduction of the appropriate master production instruction. These
records should be numbered with a unique batch or identification number, dated and signed
when issued.
 Documentation of completion of each significant step in the batch production records (batch
production and control records) should include:
 Dates and, when appropriate, times.
 Identity of major equipment (e.g., reactors, driers, mills, etc.) used.
 Specific identification of each batch, including weights, measures, and batch numbers of raw
materials, intermediates, or any reprocessed materials used during manufacturing
 Actual results recorded for critical process parameters.
 Any sampling performed.
 Signatures of the persons performing and directly supervising or checking each critical step in the
operation.
 In-process and laboratory test results. | Actual yield at appropriate phases or times. Description of
packaging and label for intermediate or API. Representative label of API or intermediate if made
commercially available.
 Any deviation noted, its evaluation, investigation conducted (if appropriate) or reference to that
investigation if stored separately.
 Results of release testing.
Batch Production Record Review:

Written procedures should be established and followed for the review and approval of U
batch production and laboratory control records, including packaging and labelling, to
determine compliance of the intermediate or API with established specifications before a
batch is released or distributed. Batch production and laboratory control records of critical
process steps should be reviewed and approved by the quality unit(s) before an API batch
is released or distributed.
Preparation of Batch Production Record (BPRs):
Batch Production record is a written document of the batch that is prepared during the
pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole
manufacturing process step by step. There are several stages of the pharmaceutical product
manufacturing process. All stages are included in the batch production record from issuance of the
raw material to the final packaging. Every batch has a separate, BPR having the batch history of
batch production. Documents and the proofs are attached in the BPR during the manufacturing
process.
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A good Batch Production Record format should contain following parts:
1. Batch Record: Very first page of the BMR has all records about the batch as batch number,
batch size, composition, master formula record referred, weight of the batch shelf life, storage
conditions, manufacturing license number, manufacturing date, expiry date, date of starting
and date of completion.
2. General Instruction for Manufacturing: Health and safety instructions to the operators and the
manufacturing chemist are written those should be followed during the manufacturing process
regarding the material and equipments used during manufacturing
3. Equipment Cleaning Record: Checklist of the cleaning of all equipments is prepared; those are
used in the manufacturing of the batch including the previous product, batch and date of cleaning.
Cleaning of the equipments should be checked by the quality assurance.
4. Bill of Materials: List of the raw material should have the quantity of the materials with their AR
numbers. Weights of the materials should be verified by quality assurance. If tablets are coated
then coating material should be included.
5. Manufacturing Process: Manufacturing process should be written step by step in easy language.
Milling, sifting, drying, lubrication, compression, coating and packing having all instruction with
process time should be written. Checklist for line clearance should also be attached before starting
every process. After completion of the every stage, tablets must be checked for the compliance of
the specification of that stage. Results should be attached with the batch manufacturing record.
6. Yield: Yield of the batch should be calculated at the end of every stage to calculate the
process loss. Final yield should be calculated at the end of the manufacturing that should not be
less than 99.00%.
7. Abbreviations: List of the abbreviations used in the document should be made to understand
the BPR easily.
8. History of Chances: At the end, the document should have a list of the changes in the document
including the revision number and the date of the change
RAJAT RASTOGI Page-55

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FORMAT OF BATCH MANUFACTURING RECORD

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15. Products associated with Maxmed Lifesciences Pvt Ltd
 PRODUCT NAME  SALT COMPOSITION

 Cefomed 50mg Syrup Cefpodoxime Proxetil (50mg)
 Maxclave 500mg/125mg Tablet Amoxycillin (500mg) + Clavulanic
Acid (125mg)
 Maxgra 180mg Tablet Fexofenadine (180mg)
 Maxime 250mg Tablet Cefuroxime (250mg)
 M Penem 500mg Injection Meropenem (500mg)
 Maxime 500mg Tablet Cefuroxime (250mg)
 Albro Syrup Bromhexine (4mg) + Guaifenesin
(50mg) + Menthol (2.5mg) +
Terbutaline (1.25mg)
 Amzome 1000mg Injection Ceftriaxone (1000mg)
 M Penem 1000mg Injection Meropenem (1000mg)
 Nim S 100mg/10mg Tablet Nimesulide (100mg) +
Serratiopeptidase (10mg)
 Diace GM Tablet Glucosamine (750mg) + Diacerein
(50mg) + Methyl Sulfonyl Methane
(250mg)
 M Tax 1000mg Injection Cefotaxime (1000mg)
 Max PT 4000mg/500mg Injection Piperacillin (4000mg) + Tazobactum
(500mg)
 Maxclave 1000mg/200mg Injection Amoxycillin (1000mg) + Clavulanic
Acid (200mg)

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16. CONCLUSION
Industrial training is very much essential for Pharmacy Students. It is also a great opportunity
to acquire practical knowledge. During my training period, in the industry I acquired lots of
experiences in Pharmaceutical Production and Production management. This will help me to clarify
my theory knowledge. I hope and pray that it will help me much in my future profession.
During our training period, we had seen the various instruments and apparatus in the industry.
The highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.
It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in
each and every section. And the similar guideline was seen followed in MAXMED LIFESCIENCE
Pvt. Ltd., Rudarpur, Uttrakhand. It helped us to acquire knowledge on punctuality, regularity and
working environments in industries.
The friendly working environment in Maxmed lifescience Pvt. Ltd. will remain in our mind
in near future. Hence, we can say that our goal of attending the industrial tour is fulfilled. We
acknowledge the great help “Maxmmed lifescience Pvt. Ltd”.
...RAJAT RASTOGI

ROLL NO - 19100460500035

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lOMoAR cPSD| 15737326

INDUSTRIAL TRAINING REPORT

MORADABAD COLLEGE OF PHARMACY MORADABAD

Ms. Neha Gupta Dr. Subhranshu Panda

DR. APJ ABDUL KALAM TECHNICAL UNIVERSITY, LUCKNOW

MIT College of Pharmacy , Moradabad

successfully carried out by Rajat Rastogi at the MIT COLLEGE OF

PHARMACY , Moradabad under the guidance of Neha Gupta (Assistant

Professor), Mit College of Pharmacy, Moradabad

Dr. Subhranshu Panda

MIT College Of Pharmacy , Moradabad

This is to certify that RAJAT RASTOGI Roll No. 1910460500035 has

Ms. Neha Gupta

MIT College of Pharmacy, Moradabad

I hereby declare that the Report work entitled “Industrial Training”

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According to curriculum of a four year integrated degree course of Bachelor of

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INDUSTRIAL TRANING REPORT

S.No. Topic Page No.

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1. INDUSTRIAL TRAINING CERTIFICATE

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Maxmed life sciences pvt ltd

 It is classified as Non-govt company and is registered at Registrar of Companies, Delhi. Its

 Maxmed Life Sciences Private Limited's Corporate Identification Number is (CIN)

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At Maxmed , we believe that contributing back to the society is not only a

 Raw Material Store

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4. RAW MATERIAL STORE

Fig.1 – Raw Material Store

STEPS INVOLVE IN RM STORE

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 After receiving the raw material check he “Observation on pack”.

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 Wear gloves and nose mask during all manufacturing process.

 Get line clearance from QA for manufacturing.

 Always transfer solution to the manufacturing vessels through 20 meshes.

 Send a test request to QC after manufacturing is completed.

 Check calibration of respective equipment/machine before use.

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5. TABLET MANUFACTURING SECTION

B. Non-active Ingredients: six major excipient categories

There are three methods of preparing tablet granulations. Such as:

 Each of these methods has its advantages and disadvantages.

1. Milling of drugs and excipients.

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Fig 2. Sifter Fig 3. Planetary Mixer

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