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INTERNSHIP REPORT
INTERNSHIP AT:
ENVOY PHARMACEUTICAL (Pvt) LTD.
INTERNSHIP BY:
Rai Waqas Ali
4th Prof.
Lahore College Of Pharmaceutical Sciences
Adviser & Supervisor of Internship Report:
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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.
DURATION 31 Aug 2015 TO 30 September 2015
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ACKNOWLEDGEMENT:
Being Muslims No Acknowledgement Goes Without Praising To
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 Pharmaceuticals.The whole staff of organization was
cooperative and helpful.
I sincerely express my thanks & gratitude to the honorableand respected
Production Manager Sir Dr.SARMATTAMJEED AFZALwho provided
me with an opportunity of internship and to writeon such a unique organization
I am obliged to intend my thanks to all staff members of ENVOY Pharmaceuticals
for extraordinary guidance and tremendous cooperation throughout the tenure
of internship.
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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 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 controland
quality assurance. Envoy manufacture all forms of drug delivery systems like, solid
orals (tablets, capsules, dry suspensions), liquid orals (syrups, suspensions), and
injectable.
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MOTO OF ENVOY PHARMACEUTICAL
ENVOY Pharmaceuticals is a name of trust, excellence and quality in the
pharmaceutical industry of Pakistan. We striveto serve the humanity in the best
possibleway by providing them a wide range of innovative and quality medicines.
This is becauseEnvoy:
AIMS & OBJECTIVES:
Following are the aims & objectives of ENVOY pharmaceuticals:
• To establish the marketing relationships with the leading international
pharmaceutical companies in future by launching their innovativeand
research product
• To discover new ways, technologies and products to manage health
• To promote the growth and success of its associates and international
competitiveness and export performanceof industry.
• To offer effective solutions for various healthcare challenges, with
products and services that are well-focused, within customers reach and
contribute to improved healthcare of the people of Pakistan.
• To develop and promote Pakistan image as an attractive manufacturing
giant in innovativehealthcare products.
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Products
These are following few products of ENVOY Pharmaceutical:
 Akurate (Cefixime) Cap/Sus 400 & 100 mg
 Enspor (Cefaclor) Cap/sus/syp 250mg ‘125 mg
 Kombat (Cephradine) Tab/sus250’500mg
 Mylid(Azithromycin) Cap 250 mg
 Ancip(Ciprofloxacin) Tab250;500mg
 Aligant (Levofloxacin) Tab 250.500 mg
 Aknidox (Doxycycline) Cap100 mg
 Brilgen(Ceftriaxone) Inj1 gm
 Ometor (Omeprazole) Cap 20 mg
 Emage (Esomeprazole) Cap 20,40 mg
 Desgen(Deloratadine) Tab 5 mg
 Deconazole (Fluconazole) Cap. 150mg
 Ensp (Cefaclor) Drops
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TOLL MANUFACTURING:
An arrangement in which a company (which has specializedequipment) processes
raw materials or semifinished goods for another company. It is alsocalled Toll
processing.
ENVOY Pharmaceutical currently Toll manufacturing with
following pharmaceutical Industries:
1. Aqmar Pharmaceutical, Karachi
2. Genista Pharmaceutical, Karachi
3. Dermagen Laboratories, Lahore
4. Relliance Pharmaceutical, Lahore
5 Winlet Pharmaceutical, Lahore
6 Azee Pharmaceutical, Lahore
7 Novotek Pharmaceutical, Lahore
Nature of
Organization:
Nature of the Envoy Pharmaceutical (Pvt) Ltd. is consumer
consumable. It is providing the quality products up to the mark to
improve the health of the patients by targeting a wide rage of doctors
(from general physicians to consultants).
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DEPARTMENTS OF INDUSTRY:
 The Company is involved in the manufacturing of almost all segments
of products having its independent manufacturing sections whichare
controlled with centrally air-handling system. There are following main
departments of ENVOY Pharmaceutical.
 Ware house
Raw Material Store
Qurantine Area
Finish Good Store
 Production department
 Quality control department
 Procurementdepartment
 Business development department
 I.T department
 Marketing department
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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.
 Manager store & distribution
 Distribution in charge
 Systemoperator
 Raw material operator
 Finish Good operator
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 controlinventory 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.
RAW MATERIAL STORE:
Raw material store was further divided into following:
1. Quarantinearea
 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:
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 controllaboratory". The sampling is
performed according to specific procedures by trained personnel.
This area is divided into two sections
 Packing material quarantine
In this section packing material for differentdosage forms is kept under
recommended and controlled atmosphere
 Raw material quarantine
In this section raw material is kept under normal conditions active
pharmaceutical ingredients is kept in 15-25 C®, excipients are kept at 25 C®
in subsection of this area
 Chiller area
In this area normally temperature sensitiveproducts are kept in separate area to
prevent them fromdamage or detoriation.
 Dispensing area
Dispensing area is also presentin raw material section where dispensing is
performed under manufacturing order of a productat time of dispensing 4
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personnel’s should be presentthere to check the process of dispensing according
to SOP.
 Production pharmacist
 Q.A pharmacist
 Raw material store pharmacist
 Raw material dispenser
PURCHASE ORDER FOR RAW MATERIAL:
A stockdelivery report is prepared. Checking of documentation is done.COAis
issued. The Assistant Store Manager receives the raw materials and transfers it to
the quarantine with the label “Quarantined” before getting it transfer to the bulk
after clearance from QCD. The QCD collects the sample and reports for its release,
it is according to the specifications or rejection if not. After rejection from Quality
Control Department, red “Rejected” slip is pasted on each of the Quarantined
material and the “Quarantined” slip is removed. After released by the Quality
Control Department, green “Released”Slip is pasted on each of the Quarantined
material and the “Quarantined” slip is removed. The material released
information’s is entered in the material log sheet. The Store Keeper manages to
transfer the RM to the bulk with necessary information pasted on it. Two copies of
GRN after release of R/M from QC are proposed. Onecopyof GRN is retained by
store keeper and one copyis send to accounts department for costing. The Store
Keeper (Raw Material) transfers whole the consignment of the material with the
help of section workers by means of trolley, lifter to the bulk store.
ISSUANCE OF RAW MATERIAL:
The weighing of raw materials is carried out in the presence of pharmacist.
Production Pharmacist checks all the Raw Material by weight/volume on the
weighing balance according to manufacturing order. After weighing, the raw
material is transferred in the relevant section of productiondepartment. The copy
of the manufacturing order is kept by the Assistant Store Manager for record and
another copyis given to production pharmacist.
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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 productionteam 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:
 General Tablet Section
 General Capsule Section
 Oral Liquids Section
 Dry Powder Injectible Section
 Cephalosporins (Oral) Section
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 The Cephalosporin (Oral) Section has been further divided into two areas
i.e.
 • Cephalosporin Dry PowderSection.
 • Cephalosporin Capsules Section.
 And have the latestmachinery including:
 • Cone Mixer.
 • De-humidifier.
 • Semi-Automatic Capsule Filling Machine.
 • Bottle Blowing Machine.
 • Semi-Automatic Powder Filling Machine.
 Role of production department
 Whole pharmaceutical stand on this department
 Manufacturing of differentpharmaceutical products are controlled by this
department
 This department producetablets capsules oral liquid preparation in
industry and other pharmaceutical dosages
 Role of production department in industry is to make quality medicine
 Procedure of manufacturing in production area
In production area following sequences is followed for proper manufacturing of
medicine
 Generation of M.O (manufacturing order) under instruction of business
development department that pass buyers order of medicine to production
department
 M.O is checked by Q.C department API quantity is checked and signed by
Q.Cif quantity is within reign otherwiseit will be rejected
 M.O is sent to raw material storeand dispensed according to cGMP
 Dispensed material is shifted into production area for further processing
and manufacturing of medicines
 Oralliquid preparation procedureis different tablet and capsules re quit
different fromliquid preparation all these will be discussed later
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 For sterile preparation sterile material is dispensed in sterile area under
laminar air flow hood
 Personnel in Production department
These are following personnelin production department
 Production manager
 Assistantproduction manager
 Tablet section in-charge
 Capsule section in-charge
 Oralliquid 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)
STEPS INVOLVED IN TABLET MANUFACTURING:
• DISPENSING OF RAW MATERIAL:
Tabletting process starts with dispensing of active ingredients. Weigh and dispense
system begins with a pharmacist getting a bill of materials for ingredients that
make up a recipe for a batch to be manufactured. Each material must be gathered
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from a warehouse. Then it is verified as the propermaterial, 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 purposeof 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
• LUBRICATION & FINAL MIXING:
Final mixing is done in DC (Double Cone) mixer.
DOUBLE CONE MIXER
• COMPRESSION:
Rotary tablet machine is used for compression. Zp-
17and ZP-33 are being used.
• COATING:
Spray Gun (High Efficiency Coating Machine)
&
Thiocota is used for coating of tablets.
SPRAY GUN MACHINE
• LABELING & PACKING:
Two types of packing is done:
• Alu-PVC.
• Alu-Alu.
Tablets are packaged into strip and blister packaging
and then finally in shippers.
 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-PVC PACKING MACHINE
 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:
“Capsules are solid unit dosage form of medicament.”
Followings are someexamples of capsules manufactured by ENVOY;
 Ometor (Omeprazole)
 Emage (Esomeprazole)
 Mylid (Azithromycin)
 Akurate (Cefixime)
STEPS INVOLVED IN CAPSULE MANUFACTURING:
• DISPENSING OF RAW MATERIAL:
Capsulation process starts with dispensing of active ingredients. Weigh
and dispense system begins with a pharmacist getting a bill of materials for
ingredients that make up a recipe for a batch to be manufactured. Each material
must be gathered from a warehouse. Then it is verified as the propermaterial,
carefully weighed, checked again, and finally readed for mixing in the recipe.
• 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.
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CAPSULE FILLING MACHINE
• CAPSULE POLISHING:
After capsule filling capsules were
polishes in full automatic capsule
polishing machine.
CAPSULE POLISHING MACHINE
• LABELING & PACKING:
Two types of packing is done:
• Alu-PVC.
• Alu-Alu.
Capsules are packaged into strip and blister
packaging and then finally in shippers
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
 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 aremanufactured by ENVOY is
 Anspor (Cefaclor)
STEPS INVOLVED IN SYRUP MANUFACTURING:
• Dispensing of ingredients.
• Prepared simple syrup.
• Add ingredients one by one.
• Filling of syrup.
• Labeling & Packing.
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
A Pharmaceutical suspension is a coarse dispersion in which internal phase is
dispersed uniformly throughoutthe external phase. The internal phaseconsisting
of insoluble solid
particles having a specific range of size which is maintained uniformly throughout
the suspending vehiclewith aid of single or combination of suspending agent. The
external phase(suspending medium) is generally aqueous in some instance, may
be an organic or oily liquid for non oral use. In ENVOY following suspensions are
prepared
 Akurate(Cefixime)
 Kombat (Cephradine)
DRY POWDER SUSPENSION SECTION:
Commercial manufacturers provide them in dry powder or granules form for
reconstitution with prescribed amount of purified water.
STEPS INVOLVED IN DRY POWDER SUSPENSION
MANUFACTURING:
• Dispensing of ingredients.
• Reduction of sizes of ingredients.
• Mixing of all ingredients.
• Filling.
• Labeling & packing.
APP1ARATUS:
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• Fitz mill.
• Cone mixer.
• Dehumidifier.
• Filling machine.
DRY POWDER SUSPENSION FILLING MACHINE
PACKING ROOM:
In ENVOY pharmaceutical industry there are 2 packing hall.
INSTRUCTIONS FOR PACKING:
 Packing area must be cleaned with detergent.
 Packing belt must contain the identification slip.
 Material which is to packed should be released for packing by Quality
assurance department.
 Before staring the packing, get line clearance from Quality Assurance
department.
 All the packaging material of the productto be packed should be checked
and approved by In-charge pharmacist and Q.A inspector respectively.
 No irrelevant material should b present in packing area.
 Batch Manufacturing Record should be present in packing area during
packing.
 Shipper packed must contain the proper identification ship.
 Transfer the shippers to Finished GoodsStoreat the completion of
packaging process after getting approval.
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 Shipper in Finished Goods Storemust 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,countthe rejected material .
QUALITY CONTROL DEPARTMENT:
“Quality is our priority.”
“Quality is never an accident, always the result of intelligent effort.”
The quality controldepartment is responsible to ensure that all materials
meet the established criteria throughout all phases of the process.Raw materials,
components, and packaging and labeling are examined and tested according to a
rigorous written program designed to assure uniformity from batch to batch. Every
raw material received is tested for identity and conformance to specifications.
Every bottle, cap, and label is examined to assure that they match the written
specifications. During the manufacture of all batches of all products, in-process
samples are tested and the results documented. If any results fall outside of the
written specifications, the productis rejected and the information is submitted to
the research and development group for evaluation and further disposition.
Samples of finished, packaged productare tested for stability to allow for
determination of expiration dating. Accelerated stability testing as well as real time
stability testing isdone concurrently to validate the results of the tests.
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 byresearch 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 formaintaining standards and not for creating them. The quality control
department has the responsibility and authority to approve or reject all
components, drug productcontainers, 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 procedureat 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.
FLOW CHART OF Q.C
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Raw Material Inspection
Raw Material
Receipt
Verification
Sampling
Under Test
Q.C Testing
Approved Rejected
For manufacturing Return to supplier/Destruction
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FINISHED PRODUCT INSECPTION
Completion of Batch of
Finished products
Sampling by Q.A
Under Test
Q.C testing
Preparation of Report & checking
Approved Rejected
For Dispatch Reprocess/ Destruction
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Quality Control test for material by Q.C
department
For different materials and dosageformdifferent tests are performed, following
of them are
 Test for Raw Material
For testing of raw material following test are performed according to SOP or
referenced set by supplier
 Descriptionor Physical appearance ( crystalline, powder, smell, color,)
 Solubility (solubility is check by dissolving in alcohol, chloroformor in water
if substanceorganic in nature and non polar t will dissolvein alcohol and
chloroformand if substanceis inorganic n polar in nature will easily dissolve
in water)
 Identification (identified by using FTIR, TLC, UV spectrometer)
 pH (checked by pH meter pH should be within range as recommended by
official books)
 Viscosity (viscosity is checked by viscometer and it should be within range
as recommended by official book)
 Assay (percentagepurity of sample is checked by analyzing the sample by
using U.V spectrometer or HPLC, FTIRbut mostly used apparatus is U.V
spectrophotometer)
 LOD/ Loss on Drying
Wt. of empty Petri-dish = A
Wt. of Petri-dish + Sample = B
Wt. of sample = B-A = C
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After drying at 105C® for 30 minutes wt. of Petri-dish + sample = D
Differencebetween wt. before drying and after drying = B-D = E
% 𝐿𝑂𝐷 =
Diffrence
Wt.of Sample
x 100
=
E
c
x 100 = E
 Test for Tablets
For finished product following test are performed
 Descriptionor Physical appearance ( crystalline, powder, smell, color, size,
shape)
 Identification (identified by using FTIR, TLC, UV spectrometer)
 Assay (percentagepurity of sample is checked by analyzing the sample by
using U.V spectrometer or HPLC, FTIRbut mostly used apparatus is U.V
spectrophotometer)
 Shining test
 Dissolutiontime
 Packaging test
 Direct loss test
For bulk only assay is performed to check its percentage purity
 Test for capsules
For capsules following tests are performed
 Descriptionor Physical appearance ( crystalline, powder, smell, color, size,
shape)
 Identification (identified by using FTIR, TLC, UV spectrometer)
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 Assay (percentagepurity of sample is checked by analyzing the sample by
using U.V spectrometer or HPLC, FTIRbut mostly used apparatus is U.V
spectrophotometer)
 Shining test
 Dissolutiontime
 Packaging test
 Direct loss test
 Test for liquids
For liquids preparation following tests are performed
 Description
 Weight variation
 Identificationtest
 Viscosity
 pH
 Assay
 Cap sealing
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INSTRUMENTS IN Q.C DEPARTMENT:
Different instruments are use for testing in Q.C department:
• Fourier Transform Infrared Spectrophotometer.
• UV/visible Spectrophotometer.
• High Performance Liquid Chromatography.
• Moisture Analyzer.
• Automatic Polarimeter.
• Dissolution Apparatus.
• Disintegration TestApparatus.
• Thin Layer Chromatography.
• Hot Plate Magnetic Stirrer.
• Viscometer.
• Sonication Bath.
• Melting Point Apparatus.
• Refractometer.
• Friability Apparatus.
• Vacuum Pump Filtration Assembly.
• Cooled Incubator.
• Water Bath Digital.
• Forced Convection Oven.
• pH meter.
• Conductivity meter.
• Centrifuge Machine.
• Dead Weights.
• Analytical Balance.
• Desiccators
• Atomic AbsorptionSpectrophotometer.
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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 productwill 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 ENVOY, 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.
Role of Quality Assurance in industry
 Temperature check
 Humidity checking
 Line clearance (at different stages, in line clearance our focus is on
cleanliness proper identification of productbatch No. packing procedure,
productlabeling)
 Stability testing
 Maintain record
 Dispatch testing
 Handling of market complains
 Dispensing checking
 In-processtesting
 SOP designing
 Workers training
 Validation
 Self inspection / internal audit
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 Art work
 Market return
In-process test for Tablets
Q.C performfollowing test for in-process testing of tablets
 Appearance(color, size, shape)
 Wt. variation
80 mg o <± 10 %
80 – 250 mg ±7.5%
> 250mg ± 5%
 Averagewt.
 Disintegration
 Hardness
 Thickness
 Diameter
 Dissolution time
 Friability test
Wt. before=A
Wt. after= B
𝑥 =
A − B
𝐴
X 100
In-process test for Capsule
 Physicalappearance
 Disintegration test
 Averagewt.
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 Wt. variation
350 mg or <± 10 %
350 mg or <± 7.5 %
In-process test for Liquid Preparation
 pH
 Viscosity
 Weight per ml
Wt. of empty pychno-meter = A
Wt. of pychno-meter + liquid/ suspension =B
Wt of liquid/ suspension =B – A =C
Wt./ml =
C
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 Deliverable volume
RESEARCH & DEVELOPMENT DEPARTMENT:
ENVOY Pharmaceuticals has dedicated research teams at both national and
international level. Their R&D team has all the necessary skills and equipment
to formulate and produce even unique and new combinations of medicine.
There is a R&D department in ENOY which worked in discovering new
knowledge about products, processes, and services and then applying that
knowledge to create new and improved products, processes and services that fill
market needs.
They used following apparatus:
• 3 In 1 apparatus(DT+DIS+FR).
• Aluminum foil sealing machine.
• Manual ointment filling machine.
• Sugar coating machine.
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• Cone mixer .
FINISH GOOD STORE:
Finished products are stored in this area. Temperature and humidity is controlled
here to assure stability and effectiveness of products. Productsthat 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.
TodayENVOY Pharmaceuticals (Pvt) Ltd. products are being promoted & sold in
various countries around the globe .
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 controltests to ensure that all the procedures carried out during
production are according to GMP.
37
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 productionareas but even workers helped me to
understand important procedures regarding the production. The entire journey of
internship allowed me to identify my strengths and weaknesses, and use bothof
them to the bestadvantage of my career.
Negative points
There is no negative point in my observation in my time of internship in ENVOY.
Worker’s Uniformshould benew and their color should not faded. indoor shoes
are strictly prohibited outside the plant.
CONCLUSION & RECOMMENDATIONS
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 disposalof 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
38
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 bestqualifications.
Therefore, it is necessary to provide the best of facilities to the health professionals
especially the pharmacists becausethey play a vital role in ensuring health.
Otherwise, our nation will suffer and when nation suffers, the future suffers. And
as an internee I want more time to learnits very short durationfor me to take a
round of practical work especially inthe 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, that’s all improve my knowledge and my skills.
Thank You
ENVOY
for giving me chance to learn and explore the industrial aspect of pharmacy .

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Internship report for pharmaceutical industry

  • 1. 1 INTERNSHIP REPORT INTERNSHIP AT: ENVOY PHARMACEUTICAL (Pvt) LTD. INTERNSHIP BY: Rai Waqas Ali 4th Prof. Lahore College Of Pharmaceutical Sciences Adviser & Supervisor of Internship Report:
  • 2. 2 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. DURATION 31 Aug 2015 TO 30 September 2015
  • 3. 3 ACKNOWLEDGEMENT: Being Muslims No Acknowledgement Goes Without Praising To 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 Pharmaceuticals.The whole staff of organization was cooperative and helpful. I sincerely express my thanks & gratitude to the honorableand respected Production Manager Sir Dr.SARMATTAMJEED AFZALwho provided me with an opportunity of internship and to writeon such a unique organization I am obliged to intend my thanks to all staff members of ENVOY Pharmaceuticals for extraordinary guidance and tremendous cooperation throughout the tenure of internship.
  • 4. 4 TABLE OF CONTENTS: • Introduction. • Industry Overview. • Moto of Envoy Pharmaceutical. • Aim &Objective. • Departments of Industry. • Toll Manufacturing. • Observation. • Discussion. • Conclusion & Recommendation.
  • 5. 5 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 controland quality assurance. Envoy manufacture all forms of drug delivery systems like, solid orals (tablets, capsules, dry suspensions), liquid orals (syrups, suspensions), and injectable.
  • 6. 6 MOTO OF ENVOY PHARMACEUTICAL ENVOY Pharmaceuticals is a name of trust, excellence and quality in the pharmaceutical industry of Pakistan. We striveto serve the humanity in the best possibleway by providing them a wide range of innovative and quality medicines. This is becauseEnvoy: AIMS & OBJECTIVES: Following are the aims & objectives of ENVOY pharmaceuticals: • To establish the marketing relationships with the leading international pharmaceutical companies in future by launching their innovativeand research product • To discover new ways, technologies and products to manage health • To promote the growth and success of its associates and international competitiveness and export performanceof industry. • To offer effective solutions for various healthcare challenges, with products and services that are well-focused, within customers reach and contribute to improved healthcare of the people of Pakistan. • To develop and promote Pakistan image as an attractive manufacturing giant in innovativehealthcare products.
  • 7. 7 Products These are following few products of ENVOY Pharmaceutical:  Akurate (Cefixime) Cap/Sus 400 & 100 mg  Enspor (Cefaclor) Cap/sus/syp 250mg ‘125 mg  Kombat (Cephradine) Tab/sus250’500mg  Mylid(Azithromycin) Cap 250 mg  Ancip(Ciprofloxacin) Tab250;500mg  Aligant (Levofloxacin) Tab 250.500 mg  Aknidox (Doxycycline) Cap100 mg  Brilgen(Ceftriaxone) Inj1 gm  Ometor (Omeprazole) Cap 20 mg  Emage (Esomeprazole) Cap 20,40 mg  Desgen(Deloratadine) Tab 5 mg  Deconazole (Fluconazole) Cap. 150mg  Ensp (Cefaclor) Drops
  • 8. 8 TOLL MANUFACTURING: An arrangement in which a company (which has specializedequipment) processes raw materials or semifinished goods for another company. It is alsocalled Toll processing. ENVOY Pharmaceutical currently Toll manufacturing with following pharmaceutical Industries: 1. Aqmar Pharmaceutical, Karachi 2. Genista Pharmaceutical, Karachi 3. Dermagen Laboratories, Lahore 4. Relliance Pharmaceutical, Lahore 5 Winlet Pharmaceutical, Lahore 6 Azee Pharmaceutical, Lahore 7 Novotek Pharmaceutical, Lahore Nature of Organization: Nature of the Envoy Pharmaceutical (Pvt) Ltd. is consumer consumable. It is providing the quality products up to the mark to improve the health of the patients by targeting a wide rage of doctors (from general physicians to consultants).
  • 9. 9 DEPARTMENTS OF INDUSTRY:  The Company is involved in the manufacturing of almost all segments of products having its independent manufacturing sections whichare controlled with centrally air-handling system. There are following main departments of ENVOY Pharmaceutical.  Ware house Raw Material Store Qurantine Area Finish Good Store  Production department  Quality control department  Procurementdepartment  Business development department  I.T department  Marketing department
  • 10. 10 WARE HOUSE It receives raw material. Until this material is cleared it is remains there. Temperature and humidity is kept under control.  Manager store & distribution  Distribution in charge  Systemoperator  Raw material operator  Finish Good operator 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 controlinventory 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. RAW MATERIAL STORE: Raw material store was further divided into following: 1. Quarantinearea  Packing material quarantine  Raw material quarantine 2. Excipient area 3. Active pharmaceutical ingredients
  • 11. 11  Toll  Envoy 4. Dispensing area  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 controllaboratory". The sampling is performed according to specific procedures by trained personnel. This area is divided into two sections  Packing material quarantine In this section packing material for differentdosage forms is kept under recommended and controlled atmosphere  Raw material quarantine In this section raw material is kept under normal conditions active pharmaceutical ingredients is kept in 15-25 C®, excipients are kept at 25 C® in subsection of this area  Chiller area In this area normally temperature sensitiveproducts are kept in separate area to prevent them fromdamage or detoriation.  Dispensing area Dispensing area is also presentin raw material section where dispensing is performed under manufacturing order of a productat time of dispensing 4
  • 12. 12 personnel’s should be presentthere to check the process of dispensing according to SOP.  Production pharmacist  Q.A pharmacist  Raw material store pharmacist  Raw material dispenser PURCHASE ORDER FOR RAW MATERIAL: A stockdelivery report is prepared. Checking of documentation is done.COAis issued. The Assistant Store Manager receives the raw materials and transfers it to the quarantine with the label “Quarantined” before getting it transfer to the bulk after clearance from QCD. The QCD collects the sample and reports for its release, it is according to the specifications or rejection if not. After rejection from Quality Control Department, red “Rejected” slip is pasted on each of the Quarantined material and the “Quarantined” slip is removed. After released by the Quality Control Department, green “Released”Slip is pasted on each of the Quarantined material and the “Quarantined” slip is removed. The material released information’s is entered in the material log sheet. The Store Keeper manages to transfer the RM to the bulk with necessary information pasted on it. Two copies of GRN after release of R/M from QC are proposed. Onecopyof GRN is retained by store keeper and one copyis send to accounts department for costing. The Store Keeper (Raw Material) transfers whole the consignment of the material with the help of section workers by means of trolley, lifter to the bulk store. ISSUANCE OF RAW MATERIAL: The weighing of raw materials is carried out in the presence of pharmacist. Production Pharmacist checks all the Raw Material by weight/volume on the weighing balance according to manufacturing order. After weighing, the raw material is transferred in the relevant section of productiondepartment. The copy of the manufacturing order is kept by the Assistant Store Manager for record and another copyis given to production pharmacist.
  • 13. 13 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 productionteam 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:  General Tablet Section  General Capsule Section  Oral Liquids Section  Dry Powder Injectible Section  Cephalosporins (Oral) Section
  • 14. 14  The Cephalosporin (Oral) Section has been further divided into two areas i.e.  • Cephalosporin Dry PowderSection.  • Cephalosporin Capsules Section.  And have the latestmachinery including:  • Cone Mixer.  • De-humidifier.  • Semi-Automatic Capsule Filling Machine.  • Bottle Blowing Machine.  • Semi-Automatic Powder Filling Machine.  Role of production department  Whole pharmaceutical stand on this department  Manufacturing of differentpharmaceutical products are controlled by this department  This department producetablets capsules oral liquid preparation in industry and other pharmaceutical dosages  Role of production department in industry is to make quality medicine  Procedure of manufacturing in production area In production area following sequences is followed for proper manufacturing of medicine  Generation of M.O (manufacturing order) under instruction of business development department that pass buyers order of medicine to production department  M.O is checked by Q.C department API quantity is checked and signed by Q.Cif quantity is within reign otherwiseit will be rejected  M.O is sent to raw material storeand dispensed according to cGMP  Dispensed material is shifted into production area for further processing and manufacturing of medicines  Oralliquid preparation procedureis different tablet and capsules re quit different fromliquid preparation all these will be discussed later
  • 15. 15  For sterile preparation sterile material is dispensed in sterile area under laminar air flow hood  Personnel in Production department These are following personnelin production department  Production manager  Assistantproduction manager  Tablet section in-charge  Capsule section in-charge  Oralliquid 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) STEPS INVOLVED IN TABLET MANUFACTURING: • DISPENSING OF RAW MATERIAL: Tabletting process starts with dispensing of active ingredients. Weigh and dispense system begins with a pharmacist getting a bill of materials for ingredients that make up a recipe for a batch to be manufactured. Each material must be gathered
  • 16. 16 from a warehouse. Then it is verified as the propermaterial, 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 purposeof drying.
  • 17. 17 FLUIDIZED BED DRYERTRAY DRYER • DRY GRANULATION: Oscillating granulator is used for dry granulation & mesh size used is 16.
  • 18. 18 OSCILLATING GRANULATOR • LUBRICATION & FINAL MIXING: Final mixing is done in DC (Double Cone) mixer. DOUBLE CONE MIXER • COMPRESSION: Rotary tablet machine is used for compression. Zp- 17and ZP-33 are being used. • COATING: Spray Gun (High Efficiency Coating Machine) & Thiocota is used for coating of tablets. SPRAY GUN MACHINE • LABELING & PACKING: Two types of packing is done: • Alu-PVC. • Alu-Alu. Tablets are packaged into strip and blister packaging and then finally in shippers.  Alu-PVC Packing: For Alu-PVC packing Alu-PVC blistering machine is used.
  • 19. 19 Specification: • Having heater in start. • Batch no. & Expiry date. ALU-PVC PACKING MACHINE  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.
  • 20. 20 ALU-ALU PACKING MACHINE; CAPSULE SECTION: “Capsules are solid unit dosage form of medicament.” Followings are someexamples of capsules manufactured by ENVOY;  Ometor (Omeprazole)  Emage (Esomeprazole)  Mylid (Azithromycin)  Akurate (Cefixime) STEPS INVOLVED IN CAPSULE MANUFACTURING: • DISPENSING OF RAW MATERIAL: Capsulation process starts with dispensing of active ingredients. Weigh and dispense system begins with a pharmacist getting a bill of materials for ingredients that make up a recipe for a batch to be manufactured. Each material must be gathered from a warehouse. Then it is verified as the propermaterial, carefully weighed, checked again, and finally readed for mixing in the recipe. • 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. 21 CAPSULE FILLING MACHINE • CAPSULE POLISHING: After capsule filling capsules were polishes in full automatic capsule polishing machine. CAPSULE POLISHING MACHINE • LABELING & PACKING: Two types of packing is done: • Alu-PVC. • Alu-Alu. Capsules are packaged into strip and blister packaging and then finally in shippers 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
  • 22. 22 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 aremanufactured by ENVOY is  Anspor (Cefaclor) STEPS INVOLVED IN SYRUP MANUFACTURING: • Dispensing of ingredients. • Prepared simple syrup. • Add ingredients one by one. • Filling of syrup. • Labeling & Packing. APPARATUS: • Silver son mixer (300 & 2000 liters). • R.O water storage tank. • Double stream jacket. • Syrup transfer pump. • Automatic bottle filling (4 nozzels).
  • 23. 23 SYRUP FILLING MACHINE  Suspension A Pharmaceutical suspension is a coarse dispersion in which internal phase is dispersed uniformly throughoutthe external phase. The internal phaseconsisting of insoluble solid particles having a specific range of size which is maintained uniformly throughout the suspending vehiclewith aid of single or combination of suspending agent. The external phase(suspending medium) is generally aqueous in some instance, may be an organic or oily liquid for non oral use. In ENVOY following suspensions are prepared  Akurate(Cefixime)  Kombat (Cephradine) DRY POWDER SUSPENSION SECTION: Commercial manufacturers provide them in dry powder or granules form for reconstitution with prescribed amount of purified water. STEPS INVOLVED IN DRY POWDER SUSPENSION MANUFACTURING: • Dispensing of ingredients. • Reduction of sizes of ingredients. • Mixing of all ingredients. • Filling. • Labeling & packing. APP1ARATUS:
  • 24. 24 • Fitz mill. • Cone mixer. • Dehumidifier. • Filling machine. DRY POWDER SUSPENSION FILLING MACHINE PACKING ROOM: In ENVOY pharmaceutical industry there are 2 packing hall. INSTRUCTIONS FOR PACKING:  Packing area must be cleaned with detergent.  Packing belt must contain the identification slip.  Material which is to packed should be released for packing by Quality assurance department.  Before staring the packing, get line clearance from Quality Assurance department.  All the packaging material of the productto be packed should be checked and approved by In-charge pharmacist and Q.A inspector respectively.  No irrelevant material should b present in packing area.  Batch Manufacturing Record should be present in packing area during packing.  Shipper packed must contain the proper identification ship.  Transfer the shippers to Finished GoodsStoreat the completion of packaging process after getting approval.
  • 25. 25  Shipper in Finished Goods Storemust 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,countthe rejected material . QUALITY CONTROL DEPARTMENT: “Quality is our priority.” “Quality is never an accident, always the result of intelligent effort.” The quality controldepartment is responsible to ensure that all materials meet the established criteria throughout all phases of the process.Raw materials, components, and packaging and labeling are examined and tested according to a rigorous written program designed to assure uniformity from batch to batch. Every raw material received is tested for identity and conformance to specifications. Every bottle, cap, and label is examined to assure that they match the written specifications. During the manufacture of all batches of all products, in-process samples are tested and the results documented. If any results fall outside of the written specifications, the productis rejected and the information is submitted to the research and development group for evaluation and further disposition. Samples of finished, packaged productare tested for stability to allow for determination of expiration dating. Accelerated stability testing as well as real time stability testing isdone concurrently to validate the results of the tests. 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.
  • 26. 26 • 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 byresearch 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 formaintaining standards and not for creating them. The quality control department has the responsibility and authority to approve or reject all components, drug productcontainers, 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 procedureat 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. FLOW CHART OF Q.C
  • 27. 27 Raw Material Inspection Raw Material Receipt Verification Sampling Under Test Q.C Testing Approved Rejected For manufacturing Return to supplier/Destruction
  • 28. 28 FINISHED PRODUCT INSECPTION Completion of Batch of Finished products Sampling by Q.A Under Test Q.C testing Preparation of Report & checking Approved Rejected For Dispatch Reprocess/ Destruction
  • 29. 29 Quality Control test for material by Q.C department For different materials and dosageformdifferent tests are performed, following of them are  Test for Raw Material For testing of raw material following test are performed according to SOP or referenced set by supplier  Descriptionor Physical appearance ( crystalline, powder, smell, color,)  Solubility (solubility is check by dissolving in alcohol, chloroformor in water if substanceorganic in nature and non polar t will dissolvein alcohol and chloroformand if substanceis inorganic n polar in nature will easily dissolve in water)  Identification (identified by using FTIR, TLC, UV spectrometer)  pH (checked by pH meter pH should be within range as recommended by official books)  Viscosity (viscosity is checked by viscometer and it should be within range as recommended by official book)  Assay (percentagepurity of sample is checked by analyzing the sample by using U.V spectrometer or HPLC, FTIRbut mostly used apparatus is U.V spectrophotometer)  LOD/ Loss on Drying Wt. of empty Petri-dish = A Wt. of Petri-dish + Sample = B Wt. of sample = B-A = C
  • 30. 30 After drying at 105C® for 30 minutes wt. of Petri-dish + sample = D Differencebetween wt. before drying and after drying = B-D = E % 𝐿𝑂𝐷 = Diffrence Wt.of Sample x 100 = E c x 100 = E  Test for Tablets For finished product following test are performed  Descriptionor Physical appearance ( crystalline, powder, smell, color, size, shape)  Identification (identified by using FTIR, TLC, UV spectrometer)  Assay (percentagepurity of sample is checked by analyzing the sample by using U.V spectrometer or HPLC, FTIRbut mostly used apparatus is U.V spectrophotometer)  Shining test  Dissolutiontime  Packaging test  Direct loss test For bulk only assay is performed to check its percentage purity  Test for capsules For capsules following tests are performed  Descriptionor Physical appearance ( crystalline, powder, smell, color, size, shape)  Identification (identified by using FTIR, TLC, UV spectrometer)
  • 31. 31  Assay (percentagepurity of sample is checked by analyzing the sample by using U.V spectrometer or HPLC, FTIRbut mostly used apparatus is U.V spectrophotometer)  Shining test  Dissolutiontime  Packaging test  Direct loss test  Test for liquids For liquids preparation following tests are performed  Description  Weight variation  Identificationtest  Viscosity  pH  Assay  Cap sealing
  • 32. 32 INSTRUMENTS IN Q.C DEPARTMENT: Different instruments are use for testing in Q.C department: • Fourier Transform Infrared Spectrophotometer. • UV/visible Spectrophotometer. • High Performance Liquid Chromatography. • Moisture Analyzer. • Automatic Polarimeter. • Dissolution Apparatus. • Disintegration TestApparatus. • Thin Layer Chromatography. • Hot Plate Magnetic Stirrer. • Viscometer. • Sonication Bath. • Melting Point Apparatus. • Refractometer. • Friability Apparatus. • Vacuum Pump Filtration Assembly. • Cooled Incubator. • Water Bath Digital. • Forced Convection Oven. • pH meter. • Conductivity meter. • Centrifuge Machine. • Dead Weights. • Analytical Balance. • Desiccators • Atomic AbsorptionSpectrophotometer.
  • 33. 33 QUALITY ASSURANCE DEPARTMENT: Quality Assurance (Q.A) is the sum total of organized arrangements made with the object of ensuring that productwill 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 ENVOY, 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. Role of Quality Assurance in industry  Temperature check  Humidity checking  Line clearance (at different stages, in line clearance our focus is on cleanliness proper identification of productbatch No. packing procedure, productlabeling)  Stability testing  Maintain record  Dispatch testing  Handling of market complains  Dispensing checking  In-processtesting  SOP designing  Workers training  Validation  Self inspection / internal audit
  • 34. 34  Art work  Market return In-process test for Tablets Q.C performfollowing test for in-process testing of tablets  Appearance(color, size, shape)  Wt. variation 80 mg o <± 10 % 80 – 250 mg ±7.5% > 250mg ± 5%  Averagewt.  Disintegration  Hardness  Thickness  Diameter  Dissolution time  Friability test Wt. before=A Wt. after= B 𝑥 = A − B 𝐴 X 100 In-process test for Capsule  Physicalappearance  Disintegration test  Averagewt.
  • 35. 35  Wt. variation 350 mg or <± 10 % 350 mg or <± 7.5 % In-process test for Liquid Preparation  pH  Viscosity  Weight per ml Wt. of empty pychno-meter = A Wt. of pychno-meter + liquid/ suspension =B Wt of liquid/ suspension =B – A =C Wt./ml = C 25  Deliverable volume RESEARCH & DEVELOPMENT DEPARTMENT: ENVOY Pharmaceuticals has dedicated research teams at both national and international level. Their R&D team has all the necessary skills and equipment to formulate and produce even unique and new combinations of medicine. There is a R&D department in ENOY which worked in discovering new knowledge about products, processes, and services and then applying that knowledge to create new and improved products, processes and services that fill market needs. They used following apparatus: • 3 In 1 apparatus(DT+DIS+FR). • Aluminum foil sealing machine. • Manual ointment filling machine. • Sugar coating machine.
  • 36. 36 • Cone mixer . FINISH GOOD STORE: Finished products are stored in this area. Temperature and humidity is controlled here to assure stability and effectiveness of products. Productsthat 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. TodayENVOY Pharmaceuticals (Pvt) Ltd. products are being promoted & sold in various countries around the globe . 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 controltests to ensure that all the procedures carried out during production are according to GMP.
  • 37. 37 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 productionareas but even workers helped me to understand important procedures regarding the production. The entire journey of internship allowed me to identify my strengths and weaknesses, and use bothof them to the bestadvantage of my career. Negative points There is no negative point in my observation in my time of internship in ENVOY. Worker’s Uniformshould benew and their color should not faded. indoor shoes are strictly prohibited outside the plant. CONCLUSION & RECOMMENDATIONS 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 disposalof 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
  • 38. 38 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 bestqualifications. Therefore, it is necessary to provide the best of facilities to the health professionals especially the pharmacists becausethey play a vital role in ensuring health. Otherwise, our nation will suffer and when nation suffers, the future suffers. And as an internee I want more time to learnits very short durationfor me to take a round of practical work especially inthe 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, that’s all improve my knowledge and my skills. Thank You ENVOY for giving me chance to learn and explore the industrial aspect of pharmacy .