Anshul Industrial Report
Anshul Industrial Report
(Practice School)
A
Professional Training Report
(Practice school BP-706PN22)
Submitted to
Rajiv Gandhi Proudyogiki Vishwavidhalaya, Bhopal
Towards the partial fulfillment of
The award of the Degree of
Bachelor of Pharmacy
Dr. Neetesh Kumar Jain Mr. Anil Kharia Dr. Sapna Malviya
Date:
Place: Indore
I express my deep gratitude to my esteemed and erudite Chairman and Principal Mr. Anil
Kharia, Modern Institute of Pharmaceutical Sciences and Modern Laboratory, Indore (M.P.),
for his inspiration, constant motivation and kind support.
I am also very thankful to industry personal for their support and kind behavior.
I am sincerely thankful to my supervisor Dr. Neetesh Kumar Jain and my teachers for their
guidance, collection of advice, boosting attitude and creative ideas and stupendous support
which was put in during the industrial training.
I am gratefully indebted to Dr. Sapna Malviya, H.O.I Head of Institute and Dr.Punit K.
Dwivedi Group Director, Modern Institute of Pharmaceutical Sciences, Indore, for providing
all the necessary help and facilities for my work and also for his constant support and
encouragement.
I extend my sincere thanks to all respected faculties Dr Neteesh Kumar Jain, Mr. Ankur
Joshi, Mr. Ashok Koshta, Mrs Preeti Muley, Ms. Deepti Mishra, Ms Sangeeta Dwivedi,
Mr. Shailendra Manglawat, Ms. Manisha wanjare, Ms. Gulfisha Shaikh, Ms. Purva
Khemani , Ms. Anamika Singh , Ms. Raksha Goswai, Ms. Varsha Johariya, Ms. Ayushi
Sharma, Dr.Kirti Malviya, Ms.Nishita Sharma, Ms. Vasudha Sahu, Ms. Anoopa
Purushu, Ms, Shivani Jain, Mr, Rajesh Kapse, Ms. Jaymala Mahavar, Ms. Poojashree
Verma.
My sincere gratitude extends to Laboratory staff Mr. Ravi Shukla, Mr. Brijesh Tiwari, Mr.
Sanjay Chaudhary, Mr. Manish Chaudhary, Mr. Kuldeep Solanki.
My sincere gratitude extends to Non-teaching staff Kamlesh Gupta, Pandey ji, and Prahlad
Kathare.
With great pleasure I would like to express my gratitude to my beloved sisters Vanshika
Chouhan and Nilanjani Chouhan for everlasting love, support and constant prayers.
I specially convey my gratitude to my dear friends Shrishti Verma, Khushi Yadav, Anurudh
Asati, Manish Solanki for their continuous support during the studies.
Last but not the least a loving family is the greatest force behind my achievement. I am
indebted to my parents Mr. Govind Singh Chouhan and Mrs. Anju Chouhan who
enlightened my path for professional career and gave me courage. Without their blessings,
inspiration, emotional support & encouragement, this work would not have been possible.
Above all I thank the GOD almighty who bless me with loving and supportive family along
with a strong passion and vigor that enable me to complete my work efficiently and for always
with me.
Date:
7th Sem
TRANING REPORT
INDEX
1. List of Sections/Department 02
2. 1. Introduction: 03-06
History
Mission
Board of directors
Basic information
Company USP
Warehouse $ Packaging
Product Portfolio
7. 5. Conclusion 27
List of Sections/Areas
S.NO Section/Department
2. Production Department
Type of Pharmaceutical Formulation
5. Chemical Section
6. Dissolution Section
7. Microbiology Department
8. Hot Zone
1. Introduction
History :-
Established in the year 1964, named as VOSTOK Lab, “Wilcure Remedies Private
Limited” are one of the well-known processors, suppliers and exporters engaged in
offering various types of Pharmaceutical Formulations. These medicines are known for
being stable, effective and accurate in composition. We also offer these medicines in
various potency to treat different types of diseases and aliments. Our well-developed
processing facilities allow us to offer highly effective medicine that is safe to consume.
We also give prime importance to the quality of our medicines and process these under
hygienic environment. The medicines are tested on the basis of accurate composition
before being dispatched to the clients and packaged in moisture-proof packaging material.
We have a large distribution network across East Asia, which enables us to timely deliver
the consignments. Presently, we have renowned hospitals and health care centers in our
clients list.
Our mentor “ Mr. Jay Kumar Saraf” is a man with vast knowledge in the medical field. He
has advised us to carry out our business activities with perfect honesty. Owing to his
support, we have climbed the ladder of success. We are looking franchise for our products
from different distributors.
Mission :-
Our mission at Wilcure Remedies Private Limited is to insure highest standard in quality,
customer focused service, ethical functioning, and maintaining a price advantage.
Board of directors
JAY KUMAR
00017232 Director
SARAF
SHAILENDRA
00017243 Director
SARAF
DEVENDRA
00328477 Director
SARAF
Basic Information
Nature of Business Manufacturer
Certification ISO
Total Number of
26 to 50 People
Employees
Year of
1964
Establishment
Legal Status of
Limited Company (Ltd./Pvt.Ltd.)
Firm
Company USP
Quality Measures /
Yes
Testing Facilities
A voluminous warehouse has been built, so that we are able to store our
Pharmaceutical Formulations in bulk quantity. For categorical arrangements of the
Medical Products, we have segregated our warehouse into several sections. We have
cold storage facility inside our warehouse to protect the medicines from extreme
heat. Moreover, hygienic environment is maintained inside our warehouse to provide
protection from rodents and pests.
Proper packaging of medicines are extremely important, so that these remain safe
during transit. We use tamper-proof packaging material to keep the material safe
from dust and moisture.
Product Portfolio
Category Medicines
Anti-inflammatory Tribid-P
Lox-M
Antidiarrheal & Antimalarial
Lox-Oz
Ferricol-C Capsules
Anthelmintic & Hematinic
Albex Oral Suspension
Y-Cidd Capsules
Z-Loc Tablets
Gastro esophageal & Antiemetic’s
Zol-D Capsules
Rebil Tablets
Throxyl Tablets
Cumox Dry Syrup
Lox-400
Lox-200
Antibiotics Leevok Tablets
Prolox Tz
Throxid-150
Wytax-100 Tablets
Wytax Dry Syrup
Cephalexin capsules IP
Process:-
The product sample was taken and sent for testing to QC.
Up to the resul to tested sample the productions marked with under test slip
If the sample get reject then the product shifted to the reject room and reject slip was
attached
TYPES OF SLIP: -
2)Sampling slip: -
Slip attach to the material sent for the sampling and testing.
MODERN INSTITUTE OF PHARMACEUTICAL SCIENCES Page 7
TRANING REPORT
4)Approved slip: -
If the sample pass all the test and get approved for the use then the approved slip is
attached. And it should be in green color.
5)Reject slip: -
If sample fails, the test and get rejected then the reject slip was attached. And it should
be in red color.
Sampling process:
The material bags were opened and sample was taken from each bag
using sanitized scoops.
Two samples were taken one for micro department and another for
QC department.
Entry was filled in a record book about batch no. mfg date ivt no. ARno.of
the product.
Dispensing process: -
The weighing balance should calibrate before use so that calculation should
come exact.
After weighing the slip of product name with quantity was added.
3. PRODUCTION DEPARTMENT
ORAL SOLID DOSAGE FORMS
Solid dosage form dominates the dosage form scenario on account of their obvious
advantage. They are more versatile, flexible in dosage strengths, relatively stable,
present lesser problems in formulation and them.
Example:
Tablets
Capsules
TABLETS:
Tablets are solid dosage forms containing medicinal substances with or
without suitable diluents. They are the most widely preferred form of medication
both by pharmaceutical manufacturer as well as physicians and patients.
Advantage of tablets:
Their cost is lower of all oral dosage form.
Small weight.
Smaller in sizes.
An attractive design.
Disadvantage of tablets:
Their amorphous nature or flocculent.
Drug with poor wetting, slow dissolution properties.
Bitter testing drug, drug with an objectionable odor.
This are composed of one or more drugs with other readily water soluble
ingredients & are intended to be added to sterile water or water for injection.
Tablet Manufacturing:
Dispensing
API Excipient
Sieving
Mixing
Granulation
Drying
Sieving
A) Film coating
b) Sugar Coating
Finishing
1. Critical:
Incorrect Product
Presence of more than one product
Incorrect color
2. Major:
Broken tablets
Capping
Care not fully coated
Coating not uniform in color (mottled)
Cracking / porous surface
Black particles (size < 1.0mm)
Foreign particle contamination
Film peeling off
Foreign odor
Illegal or missing debussing
Coating eruption
Cluster (group of tablets)
Others
3. Minor:
Picking
Chips
Adhering surface spots, dye spots
Surface not smooth
Poor debussing (shallow broken)
Twinning (2 tablets)
Others
More and more manufacturing companies are getting accustomed to the full
impact of strict product liability. This is enhanced by the introduction of the new
product liability legislation within the developed world. The effect of this in the
industry is that all businesses that need to continue trading profitably must take
into account safety oriented procedures that will keep product liability risks at a
minimum.
IPQC :-
IPQC stands for in process quality control, these are checks that are carried out
before the manufacturing process is completed . The function of process controls is
monitoring and if necessary, adaption of the manufacturing process in order to
comply with the specifications.
I. Friability test: -
Friability testing is a laboratory technique used by the pharmaceutical industry to
test the durability of tablets during transit. This testing involves repeatedly
dropping a sample of tablets over a fixed time, using a rotating wheel with a
baffle.
Fig. Friabilator
Its temperature remains same as the human body temperature i.e. 37℃ (±2℃)
Fluctuation occurs when hot water or cold water is employed in the disintegration
process. The time of disintegration is notes the time where tablet get dissolved
completely.
III. HardnessTester:-
Tablet hardness testing, is a laboratory technique used by the pharmaceutical
industry to determine the breaking point and structural integrity of a tablet and find
out how it changes “under condition of storage, transportation , packaging and
handling before usage” The breaking point of a tablet is based on its shape.
Principle:-
Principle of any hardness test method is forcing an indenter into the sample surface
followed by measuring dimension of the indentation.
The thickness of the matrix tablets was determined using Vernier caliper and the
results were expressed as mean values of 10 determinations, with standard
deviations.
Uses: -
• Measuring the internal diameter of a tablet
Quality Control is one of the key departments in any Parma company. After R&D
large number of people works in the QC department.
Wet Analysis
Instrumental Analysis
Once the raw material enters the factory premises and before going to the Stores
department the Quality of the material will be checked by QC department. If the
quality is as per the guidelines then the QC department approves the raw material.
This is called Raw material analysis. The concerned QC chemist will perform the
basic duties and the Group leader or Manager approves.
The In Process Analysis will be done while the Product (Chemical or Formulation)
is being Prepared/Manufactured
Finished Product analysis will be done after the Product/material is manufactured
QC Office
Instrument Section I
a) GC
b) FTIR
c) Turbidity Meter
d) Conductivity Meter
e) DSC
Instrument Section II
Instrument Section IV
a) Refractometer
Instrument Section V
a) Analytical Balance
b) UPLC
c) UV spectrophotometer
d) Water HPLC with UV detector- 6 NOS
e) Water HPLC with PDA detector- 2 NOS
Instrument Section VI
a) Ultrasonic cleaner
b) Acid Dispensing
c) Mechanical Shaker
d) Centrifuge
e) Ice maker
Chemical section
a) Friabilator
b) Tap density tester
c) Potentiometer
d) Karl Fischer titration
e) Top pan balance
Dissolution Section
Microbiology section
i) Air sampler
j) Water Bath
k) Deep freezer
Hot Zone
a) Muffle furnace
b) Melting point apparatus
c) Vacuum oven
d) Halogen moisture analyzer
e) Hot plate
f) Water bath
g) Scott voltmeter
h) Oven
List of Equipment’s:
HPLC Waters
Ph Meter Lab india analytical
UP Spectrophotometer Shimadzu
6. CONCLUSION