Professional Documents
Culture Documents
Report on
INDUSTRIAL TRAINING
By
PIYUSH RAJ SINGH CHAUHAN
(Roll. No: -1500450028)
Faculty of Pharmacy
RAJA BALWANT SINGH ENGINEERING TECHNICAL CAMPUS,
BICHPURI, AGRA
to the
DR. A.P.J ABDUL KALAM TECHNICAL UNIVERSITY, LUCKNOW
May 2018
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ACKNOWLEDGMENT
I wish to express my heart full gratitude to my institution faculty of pharmacy Raja Balwant
Singh Engineering Technical Campus, Bichpuri,Agra.
I praise god, the almighty, merciful and passionate, for providing me this opportunity and
granting me the capability to proceed successfully.
The appear in its current form due to the assistance and Guidance of several people. I would
like to offer my sincere thanks to all.
First and for most I would like to thanks to Dr. Akhand Pratap Singh, Director, R.B.S. Engg.
They gave me an excellence opportunity to learn the subjects. I express my sincere gratitude to
All those who have directly or indirectly helped me in the completion of project.
I am highly Indebted to.Dr. Shyamveer Singh Mr Krishna Kumar Agrawal,
Mr. Tripanshu Gupta, Mr. Amit Yadav, Ms. Jyoti, Ms. Pooja Bharti and other
respected faculty members.Above all I am Thankful to my parents who are the
foundation stone of the Platform on which I am standing on.
My work is the result of their blessings and hardship.
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TABLE OF CONTENTS:
• Introduction.
• Industry Overview.
• Moto of Envoy Pharmaceutical.
• Aim &Objective.
• Departments of Industry.
• Toll Manufacturing.
• Observation.
• Discussion.
• Conclusion & Recommendation.
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INTRODUCTION
PHARMACEUTICAL INDUSTRY:
INDUSTRY OVERVIEW
Founded in september 1982 Schon Pharmaceuticals has since achieved many
milestones. It is situated at 27-Km, janudi road, indore MP.
Because of their strong dedication to high quality products and services they have
developed a great portfolio of International Clients, Toll Partners, Institutional
Buyers and Marketing.
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MOTO OF SCHON PHARMACEUTICAL
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Products
These are following few products of Schon Pharmaceutical:
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DEPARTMENTS OF INDUSTRY:
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WARE HOUSE
It receives raw material. Until this material is cleared it is remains there.
Temperature and humidity is kept under control.
PREMISES:
• It is was well situated, well laid out, tidy, clean and well secured enabling
good preservation of raw material, packaging material and finished products.
• Temperature was maintained between 15-30 °C.
• Humidity was set between 35-60%.
• Job description of the warehouse included:
Responsibility to control inventory of stocks (Finished, Packaging and
Raw material Stores).
• Checking physical stocks regularly.
• Preparing Daily & Weekly Stocks Reports.
• In Schon ware house was separated into:
• Raw material store.
• Packing material store.
• Finish good store.
RAW MATERIAL STORE:
Raw material store was further divided into following:
1. Quarantine area
Packing material quarantine
Raw material quarantine
2. Excipient area
3. Active pharmaceutical ingredients
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Toll
Envoy
4. Dispensing area
For antibiotics
For cephalosporin
For general materials
5. Chiller area
QUARANTINE:
Chiller area
In this area normally temperature sensitive products are kept in separate
area to prevent them from damage or detoriation.
Dispensing area
Dispensing area is also present in raw material section where
dispensing is performed under manufacturing order of a product at
time of dispensing 4
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personnel’s should be present there to check the process of dispensing
according to SOP.
Production pharmacist
Q.A pharmacist
Raw material store pharmacist
Raw material dispenser
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DOCUMENTATION:
Following documentations were done in ware house at different stages:
• Temperature/humidity chart.
• Dispensing log book.
• Raw material requisition.
• Raw material analysis report.
• Request for retest.
• Certificate of analysis.
• Issuance of slips (Pink slip: material identification, Yellow slip: sampled at
QC, Green slip: passed from QC).
PRODUCTION AREA
Production team is committed to produce highest quality products, which can
satisfy the needs of both doctors and patients. The production team endeavors to
manufacture products that are cost-effective through best utilization of their
resources. This department is well equipped with latest equipment.
Warning in industry:
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The Cephalosporin (Oral) Section has been further divided into two areas
i.e.
• Cephalosporin Dry Powder Section.
• Cephalosporin Capsules Section.
And have the latest machinery including:
• Cone Mixer.
• De-humidifier.
• Semi-Automatic Capsule Filling Machine.
• Bottle Blowing Machine.
• Semi-Automatic Powder Filling Machine.
Production manager
Assistant production manager
Tablet section in-charge
Capsule section in-charge
Oral liquid section in-charge
Dry powder injectable section in-charge
Packing pharmacist
workers
TABLET SECTION:
“Tablets are unit solid dosage form of medicament or medicaments with
or without suitable diluents.
Types of tablets manufactured in Schon:
(Ancip)
(Aligant)
(Delide)
(Myodine)
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from a warehouse. Then it is verified as the proper material, carefully weighed,
checked again, and finally readed for mixing in the recipe.
• DRY MIXING:
Ribbon mixer is used for mixing.
RIBBON MIXER
• WET MIXING:
After dry mixing, wet mixing is done in the ribbon mixer.
• WET GRANULATION:
Wet granulation is used for wet granulation and mesh size 4 & 6 are used.
• DRYING:
• FBD (Fluidized Bed Dryer).
Or
• Tray dryer is used for the purpose of drying.
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FLUIDIZED BED DRYERTRAY DRYER
• DRY GRANULATION:
Oscillating granulator is used for dry granulation & mesh size used is 16.
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OSCILLATING GRANULATOR
• COMPRESSION:
• COATING:
Alu-PVC Packing:
For Alu-PVC packing Alu-PVC blistering
machine is used.
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Specification:
• Having heater in start.
• Batch no. & Expiry date.
Alu-AluPacking:
For Alu-Alu packing Alu-Alu blistering machine is used.
Specification:
• 3 pinch.
• Temperature 140-150°C.
• Batch no. & Expiry date is printed.
• Sealing foil.
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ALU-ALU PACKING MACHINE;
CAPSULE SECTION:
Ometor (Omeprazole)
Emage (Esomeprazole)
Mylid (Azithromycin)
Akurate (Cefixime)
• FILLING OF CAPSULE:
The mixture is filled in empty capsule. Schon pharmaceutical, presents an
exclusive array of capsule filling machinery. This capsule section machinery
is semi automatic. Capsule section machinery is simple to operate.
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CAPSULE FILLING MACHINE
• CAPSULE POLISHING:
After capsule filling capsules were
polishes in full automatic capsule
polishing machine.
INJECTABLE SECTION:
For injectables there is a need of sterile area.
In practical the term sterile area is generally
replaced by clean room. Clean rooms in
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pharmaceutical industry are classified by the cleanliness of their air. According to
Federal standard 209D class limits are decided according to the number of particles
equal to and greater than 0.5 mm in one cubic foot of air.STERILE ROOM
Akurate (Cefixime) Sus 100 mg
SYRUP SECTION:
“A viscous concentrated solution of a sugar, such as sucrose, in water or
other aqueous liquid; combined with other ingredients, such a solution
is used as a flavored vehicle for medications.”
Syrups are manufactured by Schon is
Anspor (Cefaclor)
APPARATUS:
• Silver son mixer (300 & 2000 liters).
• R.O water storage tank.
• Double stream jacket.
• Syrup transfer pump.
• Automatic bottle filling (4 nozzels).
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SYRUP FILLING MACHINE
Suspension
Akurate (Cefixime)
Kombat (Cephradine)
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APPRATUS
• Fitz mill.
• Cone mixer.
• Dehumidifier.
• Filling machine.
PACKING ROOM:
In Schon pharmaceutical industry there are 2 packing hall.
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Shipper in Finished Goods Store must contain the identification slip released
by Quality Control department.
Please the rejected material separately in a container labeled as “Rejected”.
At the completion of packing process, count the rejected material .
QUALITY POLICY:
• To gain customer’s satisfaction through manufacturing and providing high
quality pharmaceutical products. While believing in continual improvement
of our system.
• To achieve sustained growth in market share by developing satisfied
customers.
• Healthy environment to develop dedicated professional teams in order to
serve in the best interest of external and internal customers. Suppliers and
share holders.
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• To benefit the community by adopting environment friendly policies and
establishing standards of ethics.
• To improve the standard of life through the value of developing innovative
products by research and development. And to pursue Total Quality
Management.
The ISO definition states that quality control is the operational techniques and
activities that are used to fulfill requirements for quality. Quality control is a
process for maintaining standards and not for creating them. The quality control
department has the responsibility and authority to approve or reject all
components, drug product containers, closures, in-process materials, packaging
material, labeling, and drug products.
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FLOW CHART OF Q.C
Raw Material
Receipt
Verification
Sampling
Under Test
Q.C Testing
Approved Rejected
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FINISHED PRODUCT INSECPTION
Completion of Batch of
Finished products
Sampling by Q.A
Under Test
testing
Approved Rejected
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Quality Control test for material by Q.C
department
For different materials and dosage form different tests are performed, following
of them are
A Wt. of Petri-dish +
Sample = B
E
Diffrence
% 𝐿𝑂𝐷 = x 100
Wt. of
Sample
=E
x 100 = E
c
Test for
Tablets
Shining test
Dissolution time
Packaging test
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Assay (percentage purity of sample is checked by analyzing the sample
by using U.V spectrometer or HPLC, FTIR but mostly used apparatus
is U.V spectrophotometer)
Shining test
Dissolution time
Packaging test
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INSTRUMENTS IN Q.C DEPARTMENT:
Different instruments are use for testing in Q.C department:
• Centrifuge Machine.
• Dead Weights.
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• Analytical Balance.
• Desiccators
• Atomic Absorption Spectrophotometer.
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QUALITY ASSURANCE DEPARTMENT:
Quality Assurance (Q.A) is the sum total of organized arrangements made with the
object of ensuring that product will be of the quality required by their intended use.
Quality assurance is the systematic monitoring and evaluation of the various
aspects of a project, service or facility to maximize the probability that minimum
standards of quality are being attained by the production process . QA cannot
absolutely guarantee the production of quality products.
In Schon, there was a pharmacist to maintain the reliability at every stage of
manufacturing process starting from Research, Clinical studies, Quality Control,
Production, Distribution and provides information on appropriate use, and analyzes
safety and information of the products. This department assists in the strategic
direction and development of Quality Systems, standard operating procedures and
document control programs, to ensure with the company policies and regulatory
requirement.
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Art work
Market return
Wt. before =A
Wt. after= B
A−
𝑥= B X 100
𝐴
Wt. variation
350 mg or <± 10 %
350 mg or <± 7.5 %
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FINISH GOOD STORE:
Finished products are stored in this area. Temperature and humidity is controlled
here to assure stability and effectiveness of products. Products that require cold
storage are stored in refrigerator. Finished good received report is also signed.
After passing Q.C tests, quality products after manufacturing and packing are kept
here.And then products are supplied to different institutes etc.
Today Schon Pharmaceuticals (Pvt) Ltd. products are being promoted & sold in
various countries around the globe .
DISCUSSION:
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CONCLUSION:
Though serving on humanity is not only a person’s responsibility but also of
community. And this community comprises of all the members starting from the
very first of disposal of quality products. No work is penniless rather the
knowledge it keeps in, internship at any working area is a great learning experience
in itself
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