A REVIEW ON PHARMACEUTICAL INDUSTRY

A Project report submitted to

APEX UNIVERSITY

Submitted By :- Pradeep Jhangid Submitted to :- Dr. Jaya

Sharma(principal)
Enrollment no. :- APX- JPR-2021 Supervised by :- Dr. Rekha Kanwar
APEX UNIVERITY OF PHARMACEUTICAL SCIENCES , JAIPUR RAJASTHAN
 * REVIEW POINTS
 INTRODUCTION OF PHARMACEUTICAL INDUSTRY

 DEPARTMENTS OF PHARMACEUTICAL INDUSTRY

 WAREHOUSE

 PRODUCTION HOUSE :- BLENDING & SHIFTING AREA

:- COATING & GRANULATING AREA

:- PACKAGING AREA
v Q.A ( QUALITY ASSURANCE )

v Q.C ( QUALITY CONTROL ) :- Chemical Storage Area

 :- Wet Lab.

 :- Stability Room

 :- Genral Liquid Room

 :- Analytical Divison

v ENGINEERING DEPARTMENT

v R&D (RESEARCH & DEVELOPMENT ) :- F&D ( FORMULATION & DEVELOPMENT )

v :- ARD ( ANALYTICAL RESEARCH DEVELOPMENT )

v R.A ( REGULATORY AFFAIRS )

v H.R ( HUMAN RESOURCES )

 Introduction of pharmaceutical industry

 AMOL PHARMACEUTICAL PRIVATE LIMITED

 PRODUCT TECHNOLOGIES
STANDARD TABLETS
BI – LAYER TABLETS
TRI – LAYER TABLETS
EFFERVACENT TABLETS
CHEWABLE TABLETS
ORAL DISPERSIBLE TABLETS
MINI TABLETS
STANDARD CAPSULE
TABLETS IN A CAPSLE

• ESTABLISHED IN :- 1996
• LAST TURNOVER IS 550CR.

• 21 CFR Part 11 certified laboratory,

 Introduction of Pharmaceutical Industry
AMOL PHARMACEUTICAL PVT. LTD.
• Different facility regulation & compliences standards are followed to produced heigh
quality output .
• CDCSA * MHRA –

• HEALTH CANADA * NABL

• SAHPRA * MINISTRY OF AYUSH

• FSSAI

•
DEPARTMENTS OF INDUSTRY
 WAREHOUSE :-A Place which is specificially designed to store raw material or chemicals in
thermoliable rooms at specific temp. & quarantine the pharmaceutical product for 15 to 20 days .
 PRODUCTION :- A place where pharmaceutical preprations are produced consistanly with their
regulations & requirement .
 Q.A ( QUALITY ASSURANCE ) :- A part of pharmaceutical industry which is responsible to
regulate SOP , Batch card & fullfill other regulatory requirement as per guidelines and validiates
entire dept.
 Q.C ( QUALITY CONTROL ) :- TO perform chemical test Assay , raw material testing ,LOD
, MOISTURE,SAMPLING ect
Basically Q.C Dept. responsible to assure quality standards pharmaceutical product .

v ENGINEERING DEPT. :- Responsible for layout and UT changes and machine caliberation .

v R.A ( REGULATORY AFFAIRS ) :- Responsible for approvel of new product .

v R&D ( RESREACH AND DEVELOPMENT) :-

o ARD ( Analytical research and development) :- ARD focuses on the development and application of
advanced analytical techniques to explore, understand, and address complex challenges in chemistry, biology,
materials science, pharmaceuticals .
o F&D ( FORMULATION AND DEVELOPMENT ) :- Formulation and Development is a critical process in the
pharmaceutical industry because it is responsible for designing and developing medicines in a safe, effective, and
patient-friendly form.
v H.R DEPARTMENT :- Regulate rules and regulations , shift time, off leaves and Mediclaim .
WAREHOUSE

• A place where raw material or pharmaceutical product is

stored in thermoliable rooms at particular temperature .
• ROOM temperatre and humidity are maintain in warehouse to
maintain product quality .
• FIFO ( FIRST IN FIRST OUT ) Are basically used in warehouse for
further processing .
• AHU and HEPA FILTERS are used to maintain temperature in
 PRODUCTION
• A PLACE where pharmaceutical preprations or formulated .

• Thermoliable rooms are used in production house .

• MILLS ( EPIMILLS & FITZMILL)
PULVERIZE
SEIVING ( SHIFTER)

GRANULATION DRYING

BLENDING ( Bin Blender , Double Cone Blender , Octagonal blender )

METAL DETECTOR OR PASS BULK PACKAGING

SANITATION OUT
• BLENDING AND SHIFTING AREA

 EQUIPMENT IN PHARMAINDUSTRY

• FLUID BED DRYER/PROCEESOR (200 KGS)

• V-BLENDER (650, 500, 75 KGS)

 DOUBLE CONE BLENDER (100 & 2000 KGS)

 OCTAGONAL BLENDER

 VIBRO SHIFTER
• COATING AND GRANULATING AREA :-
• EQUIPMENTS :- TABLET COMPRESSION MACHINES (45, 37,
29, & 27 STATION)
• AUTO COATER

• CAPSULE FILLING MACHINES

 PACKAGING AREA

• Packaging Equipment
• Good packaging is a key differentiator for your products in the market,
both in usability and shelf life. We are well-equipped with quality
packaging equipment that helps you go to market with your unique
formulations
• ALU/ALU STRIP PACKING MACHINES

• POUCH/STICK PACK MACHINE

•
 BASIC INSTRUMENT USES IN PRODUCTION

 VIBRO SHIFTER :-The Vibro Sifter machine works on the principle of gyratory
vibrations. The material is separated based on its particle size. Once the motor gets
energized, vibration is caused in the screen/sieve making the material travel across
the sieves according to its particle size.
 TABLET COMRESSION MACHINE :- Rotary tablet press machine consists of
multiple stations and they rotate to compress powder and to form tablets. Tablet
compression machine basically works on hydraulic pressure. This pressure
performs key role in any type of Tablet Machine
• AUTO COATER :- The hot air penetrates through the tablets core layers and is
discharged from the bottom of the layers, so that the coating medium sprayed on
the surface of the tablet cores will dry rapidly and evenly, thus forming a solid and
smooth surface film on tablet.
• CAPSULE FILLING MACHINE :- In a manual operated capsule filler, the cap and body
of the capsule are detached and inserted into the loading tray while checking the
front knob. The empty capsules get poured along with the filling materials and
sealed off.
 Q.A ( Quality Assurance )
• Quality assurance (QA) is any systematic process of determining whether a product or service meets specified
requirements.
• Validates Entire Department
• QA DOCUMENTATION :-
• ISSUANCE :- In these process a document is issued by their valid process of following GDP.
• CONTROL SAMPLE RETENTION :-Store the control sample in the control sample room under lock
and key arrangements for a period of one year beyond the expiry of the batch in case of finished
product. -- PQR / APQR
• DEVATION :- when any changes occurs in any existing/othorized system by any planned or
unplanned mistake or by renewal process .
• CHANGE CONTROL :- When any changes occurs then change control responsible for any
channge .
• CAPA ( Corrective Action Or Preventive Action ) :- Corrective Action Preventive Action (CAPA)
is a process which investigates and solves problems, identifies causes, takes corrective action and
prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can
never be experienced again. CAPA can be applied in many disciplines.
• CAPA file must be closed in 3 months if due to any reason it dosent closed in 3
months that means CAPA dosent works properly .
•
.• OOS ( Out of specification ) :- The term OOS (out of
specification), is defined as those results of in process or
finished product testing, which falling out of specified limits,
that are mentioned in compendia, drug master file, or drug
application.
• OOT ( OUT OF TREND) :- Out of trend is defined as a result
of a sequence of the analytical results which conform to the
specifications but not in the expected trend with respect to the
initial or expected result

• FOR IMPORTANT POINTS Q.A :-

• GDP ( GOOD DOCUMENTATION PRACTICES ):-

- Document must be original , official or in a legal format .

- SOP Format must be align and legible or data directly recorded single
.
 DATA INTIGRITY POLICY :- This policy insures that personnel dosent
create any unethical for their commercial ,financial profits or in any
pressure .
.DATA RISK – INVOLVE adulteration and deletations .
Data can be in Paper record , Electronic , or Hybrid ( electronic + sign
papers )
Data must be ALCOA++ Atributable , legible , contempraneous ,
original , accurate and +++ indicates to complete ,
consistant, enduring & trustworthy .
 Data must be available at retention period
BDI (Breach Of Data Intigrity) :-Regulates validation ,
testing ,inspection & pest inspection .
DATA LIFECYCLE :- Data Owner DOCUMENT
RETENTION
 QC ( QUALITY CONTROL)
• Quality control in the pharmaceutical industry aims to verify
and test the medicine at various stages of production to ensure
every product is of the highest quality
• PARTS OF QUALITY CONTROL :-
• WET LAB –
A) CONDUCTIVITY METER :- measures cunductivityof various
solution with automic temp.
. Condensation .

B) MAGNETIC STIRRER :- Used to mixing of various solution by

trituration and providing .
temperature .
.• Electromagnetic Seive Shaker :- used to particle size
analyzer by different
sieve size . These Sieve Shakers
are activated by electromagnetic impulses.

 PH METER :-The principle of pH meters is wholly based on the

ion exchange between the sample and the glass electrode's
inner solution, which generates electrical voltage.

 CENTRIFUGATION MACHINE:- Centrifugation is a

• HOT AIR OVEN :- A hot air oven is a type of heat sterilization equipment used in
.
various laboratories.

• FUME HOOD :- A fume hood is a ventilated enclosure in which gases, vapors

and fumes are captured and removed from the work area .

 MUFFLE FURNANCE :- A muffle furnace is a laboratory instrument used to

heat materials to extremely high temperatures whilst isolating them from fuel
and the byproducts of combustion from the heat source.
 .
• Chemical lab ;-

• All sample prepration are prepared in chemical lab .

• Different weighing balance are used in measuring weight .

• ANALYTICAL BALANCE :- A readability up to 0.00001 grams
(0.01 mg), analytical balances are frequently used in laboratories.
• TOP LOADING BALANCE :- readability of 1 mg or less.
• MICRO BALANCE :-readability down to 0.1 µg,
 Different Glasswares are used in chemical lab :-

 ROUND BOTTOM FLASK

 MEASURING CYLINDER

 Beakers

 Petri Dishes

 Glass slides

 Graduated Cylinders
 .
GENRAL LIQID ROOM :-
• HPLC ( HEIGH PERFORMANCE LIQID CHROMATOGRAPHY) :-
used to separate identify and quantify each component in a mixture .
 It relies on pump to pass a pressurized liquid solvent containingsample
mixture through a columnfilled with absorbent material.Each
component intract with absorbent material causing different flow rates
for different components leading sepration of different component.

 TLC( THIN LAYER CHROMATOGRAPHY) :- Thin layer

chromatography (TLC), an analytical technique often used to separate
and identify compounds present in a given mixture, mixture
components are separated between a fixed stationary phase and a
liquid mobile phase by differential affinities between the two phases.
.• DISSOLUTION TESTER :- Dissolution testing measures the
extent and rate of solution formation from a dosage form, such
as tablet, capsule, ointment, etc. The dissolution of a drug is
important for its bioavailability and therapeutic effectiveness.

 DISINTEGRATION TESTER :- The disintegration test is

used to show how quickly the tablet breaks down into smaller
particles, allowing for a greater surface area and availability of
the drug when taken by a patient. Disintegration testers work
by raising and lowering a 'basket' in and out of the test
medium, for a set period of time, to see if the tablet dissolves
• KARL FISHER APPARATUS :- Karl Fischer method is the capability to
. accurately measure small amounts of moisture. Sensitivity of these
instruments is as low as 0.1 microgram (µg) of water.

LEAK TEST APPARATUS :- Leak Test Apparatus is a solid state

instrument designed for the leakage testing of food, drug and other
industrial chemical products. The instrument is used to test the quality of
packing processes in strips, blisters and sachets containing tablets,
granulates and liquids.

FRIABILITY TEST APPARATUS :- Friability Test Apparatus is a precision

instrument for measuring obression strength of the tablets. The Friability
Test Apparatus is designed as per IP/USP standards. The unit is equipped
with two transparent acrylic drums which rotate at a speed of 25 . 1 rpm.
 .
MICRO LAB ;- the primary objective is to identify viable microorganisms at every
•
stage of the production process: in the air, raw materials, water and finished
products. This enables lot release with the assurance of safety, efficacy and purity.
• Calculate the range of TPC ( Tottle plate count) , TYMC ( Tottle yeast

mould count ) .
 Detect E-Collie , salmonella ,pseudomonas , S - Aureus pathogen , staphylococcus
aureus
 Media – Solid Media ( Agar)
Liquid Media ( Nutrient Broth)
 BSCP( Buffered sodium chloride peptone ) , SCDM ( soyabean casein digest
medium)
 OR FSCD(Fluid Selenite Cystine Medium) as per USP re used to dissolved sample .

 Media prepration – 200 ml prepared media bottle – take 100 ml media – mix 10 gm
sample & leave it for 10 to 15 min.
 If yeast count less than excepted crietria then take dilution .

 Basically we incubate 3-5 days a sample for bacterial count & 5-7 days for fungal
count .
 MANITOL SALT AGAR IS USED IN DETECTION OF ISORIOUS PATHOGEN .
•
.
GENRAL EQUIPMENTS USED IN MICRO LAB

AUTOCLAVE :- AUTOCLAVE :- An autoclave is a machine that uses steam under pressure to kill
harmful bacteria, viruses, fungi, and spores on items that are placed inside a pressure vessel. The
items are heated to an appropriate sterilization temperature for a given amount of time.

INCUBATOR :- an insulated enclosure in which temperature, humidity, and other

environmental conditions can be regulated at levels optimal for growth, hatching, or
reproduction
BIOSAFETY CABINET :- Biosafety cabinets (BSCs) are one type of biocontainment
equipment used in biological laboratories to provide personnel, environmental, and
product protection
COLONY COUNTER :- Colony counters specify the number of microbial colonies present on
sample plates for maximized working efficiency in the lab.
 BOD INCUBATOR :- The BOD incubator is used to provide the ideal temperature and
conditions for the microorganisms to grow and consume oxygen. The incubator typically
has temperature control, which is set to 20°C, the standard temperature for BOD testing.
 ULTRA DEEP FREZER :- An ultra low temperature (ULT) freezer is a refrigerator that
stores contents at −80 to −86 °C (−112 to −123 °F). An ultra low temperature freezer
is commonly referred to as a "minus 80 freezer" or a "negative 80 freezer", referring
to the most common temperature standard
.