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INTERNSHIP REPORT
INTERNSHIP AT:
ENVOY PHARMACEUTICAL (Pvt) LTD.
INTERNSHIP BY:
Rai Waqas Ali
4th Prof.
Lahore College Of Pharmaceutical Sciences
DEDICATION:
I have dedicated my internship work and effort to all my teachers who
found such ability in me in ENVOY Pharmaceuticals. Without their
help I was not able to do my best efforts.
ACKNOWLEDGEMENT:
ALLAH ALMIGHTY
Knowledge has no boundaries and there is no end to it. This is
what I have come to know while preparing this repot. It has been
a
good
experience
by
taking
training
in
ENVOY
TABLE OF CONTENTS:
Introduction.
Industry Overview.
Moto of Envoy Pharmaceutical.
Aim &Objective.
Departments of Industry.
Toll Manufacturing.
Observation.
Discussion.
Conclusion & Recommendation.
INTRODUCTION
PHARMACEUTICAL INDUSTRY:
INDUSTRY OVERVIEW
Founded in september 2003 Envoy Pharmaceuticals has since achieved many
milestones. It is situated at 27-Km, Multan Road Maraka Lahore, Pakistan.
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.
Envoy pharmaceuticals is an ISO 9001:2008 certified company and therefore
assures that cGMP ( current good manufacturing practice ) and GLP (good lab
practice ) are strictly followed at all levels of manufacturing process. The
manufacturing facility has been planned keeping in view the up-to-date cGMP
rules
Envoy Pharmaceutical achieved another milestone by establishing a high-tech
Inject able Plant which is completely dedicated for manufacturing of cephalosporin
injections.
This industry has all the essential Sections of Medicine. They have a layout
according to the international standard. Itis centrally air conditioned and have latest
machinery.
Envoy is armed with the modern equipment for production, quality control and
quality assurance. Envoy manufacture all forms of drug delivery systems like, solid
orals (tablets, capsules, dry suspensions), liquid orals (syrups, suspensions), and
injectable.
Products
These are following few products of ENVOY Pharmaceutical:
Akurate (Cefixime)
Enspor (Cefaclor)
Kombat (Cephradine)
Tab/sus250500 mg
Mylid (Azithromycin)
Cap 250 mg
Ancip (Ciprofloxacin)
Tab250;500mg
Aligant (Levofloxacin)
Tab 250.500 mg
Aknidox (Doxycycline)
Cap100 mg
Brilgen (Ceftriaxone)
Ometor (Omeprazole)
Emage (Esomeprazole)
Desgen (Deloratadine)
Inj1 gm
Cap 20 mg
Cap 20,40 mg
Tab 5 mg
(Cefaclor)
Drops
TOLL MANUFACTURING:
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 ENVOY ware house was separated into:
Raw material store.
Packing material store.
Finish good store.
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For antibiotics
For cephalosporin
For general materials
5. Chiller area
QUARANTINE:
All raw materials, components, packaging, and labeling materials are
held in our "quarantine" area until they are sampled, tested and/or examined,
and released for use by our "quality control laboratory". The sampling is
performed according to specific procedures by trained personnel.
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Q.A pharmacist
Raw material store pharmacist
Raw material dispenser
DOCUMENTATION:
Following documentations were done in ware house at different stages:
Temperature/humidity chart.
13
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:
You are entering to Production Area please wear,
Cap.
Overall.
Shoes cover or change your shoes.
In ENVOY pharmaceutical Production Area is divided into following section:
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.
14
De-humidifier.
Semi-Automatic Capsule Filling Machine.
Bottle Blowing Machine.
Semi-Automatic Powder Filling Machine.
15
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 ENVOY:
(Ancip)
(Aligant)
(Delide)
(Myodine)
DRY MIXING:
Ribbon mixer is used for mixing.
16
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.
17
DRY GRANULATION:
Oscillating granulator is used for dry granulation & mesh size used is 16.
18
OSCILLATING GRANULATOR
COMPRESSION:
Rotary tablet machine is used for compression. Zp-17and ZP-33
being used.
COATING:
Spray Gun (High Efficiency Coating Machine) &
Thiocota is used for coating of tablets.
Alu-PVC Packing:
For Alu-PVC packing Alu-PVC blistering machine is used.
are
19
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 140-150C.
Batch no. & Expiry date is printed.
Sealing foil.
20
CAPSULE SECTION:
Capsules are solid unit dosage form of medicament.
Followings are some examples of capsules manufactured by
ENVOY;
Ometor
Emage
Mylid
Akurate
(Omeprazole)
(Esomeprazole)
(Azithromycin)
(Cefixime)
FILLING OF CAPSULE:
The mixture is filled in empty capsule. ENVOY pharmaceutical, presents an
exclusive array of capsule filling machinery. This capsule section machinery
is semi automatic. Capsule section machinery is simple to operate.
21
CAPSULE POLISHING:
After capsule filling capsules were polishes in full
automatic capsule polishing machine.
22
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 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
Enspor (Cefaclor)
Sus 125 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 ENVOY is
Anspor (Cefaclor)
Dispensing of ingredients.
Prepared simple syrup.
Add ingredients one by one.
Filling of syrup.
Labeling & Packing.
APPARATUS:
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24
Dispensing of ingredients.
Reduction of sizes of ingredients.
Mixing of all ingredients.
Filling.
Labeling & packing.
APP1ARATUS:
Fitz mill.
Cone mixer.
Dehumidifier.
Filling machine.
PACKING ROOM:
In ENVOY pharmaceutical industry there are 2 packing hall.
25
QUALITY POLICY:
To gain customers satisfaction through manufacturing and providing high
quality pharmaceutical products. While believing in continual improvement
of our system.
26
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.
Activities of Quality control department in ENVOY were:
Testing and release or rejection of all incoming raw materials, packing
materials, in-process / intermediates and finished products as per specified
specifications.
Maintaining testing records as per standard procedures for raw materials,
packing materials, in-process / intermediates and finished products.
Calibration of laboratory instrument / equipment.
Performing stability study.
Analytical method validation.
Preparation of standard volumetric solutions and maintain standardization
record.
Maintain Labeling procedure at all the stages and records.
Maintain working / reference standard record of products.
Analysis of complaint samples as and when required.
Follow safety norms at all the stage during handling of chemicals and using
instruments.
Follow good laboratory practices.
27
Raw Material
Receipt
Verification
Sampling
Under Test
Q.C Testing
Approved
Rejected
For manufacturing
Return to supplier/Destruction
28
29
Sampling by Q.A
Under Test
Q.C testing
Approved
For Dispatch
Rejected
Reprocess/ Destruction
30
=A
31
= B-A = C
Diffrence
x 100
Wt . of Sample
E
x 100=E
c
32
33
Centrifuge Machine.
Dead Weights.
Analytical Balance.
Desiccators
Atomic Absorption Spectrophotometer.
34
35
Art work
Market return
AB
X 100
A
Physical appearance
Disintegration test
Average wt.
Wt. variation
350 mg or < 10 %
36
C
25
Deliverable volume
3 In 1 apparatus(DT+DIS+FR).
Aluminum foil sealing machine.
Manual ointment filling machine.
Sugar coating machine.
Cone mixer .
37
DISCUSSION:
ENVOY Pharmaceutical enhanced understanding of my academic knowledge and
skills. It indeed polished my knowledge and experience. Classroom studies are
confined only to books and theoretical learning majorly. Application of these
theories and lectures delivered in classrooms differ a little from the specifically set
format.
Through this internship, I not only got the opportunity to experience but I also
learnt the applications of these theories in actual the application. I got to observe
the whole working environment of pharmaceutical industry & the important
aspects regarding the production of high quality pharmaceuticals & carrying out
important quality control tests to ensure that all the procedures carried out during
production are according to GMP.
I was able to understand the working conditions of pharmaceutical industry in
Pakistani circumstances much better than before. It also improved my general
knowledge about equipments commonly used in our industries.
Not only pharmacists in production areas but even workers helped me to
understand important procedures regarding the production. The entire journey of
38
Negative points
There is no negative point in my observation in my time of
internship in ENVOY.
Workers Uniform should be new and their color should not faded.
indoor shoes are strictly prohibited outside the plant.
CONCLUSION:
Though serving on humanity is not only a persons 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.
RECOMMENDATIONS:
I recommend is that, without fully equipped institutes as well as qualified and
devoted personals, the profession of medicines will not flourish in a developing
country like Pakistan. If high paying careers continue to attract the best and
brightest students out of country, there will not only be a shortage of professionals
in our place, but the professionals available may not have the best qualifications.
Therefore, it is necessary to provide the best of facilities to the health professionals
especially the pharmacists because they play a vital role in ensuring health.
39
Otherwise, our nation will suffer and when nation suffers, the future suffers. And
as an internee I want more time to learn its very short
duration for me to take a round of practical work
especially in the quality control area.
Lastly thanks a lot for giving me a chance to come here in
ENVOY and becoming a part of its hard team, thats all
improve my knowledge and my skills.
Thank You
ENVOY
for giving me chance to learn and explore the industrial aspect of
pharmacy .