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Internship Report
7/05/2021
To
17/08/2021
Internship at:
SCHAZOO ZAKA PHARMACEUTICALS PVT. LTD
Internship by:
Muhammad Shahzaib
4th
PROF
The University of Lahore, Defence road, Lahore
1
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 report. It has been a good experience
by taking training in SCHAZOO ZAKA Pharmaceuticals. The whole staff
of organization was cooperative and helpful.
I am obliged to intend my thanks to all staff members of SCHAZOO
ZAKA Pharmaceuticals for extraordinary guidance and tremendous
cooperation throughout the tenure of internship.
2
Contents
INTRODUCTION.............................................................................................................................................3
Products .......................................................................................................................................... 4
DEPARTMENTS OF INDUSTRY:........................................................................................................ 5
WARE HOUSE .................................................................................................................................. 5
SUBAREAS:.................................................................................................................................. 5
Dispensing area.......................................................................................................................... 6
ISSUANCE OF RAW MATERIAL: .................................................................................................. 6
Equipment’s:............................................................................................................................... 7
PRODUCTION AREA......................................................................................................................... 7
1. SOLID ANTIBIOTICS.............................................................................................................. 8
2. SOLID GENERAL ................................................................................................................. 10
QUALITY CONTROL DEPARTMENT................................................................................................ 11
Quality Control test for material by Q.C department: .................................................................. 14
Test for Raw Material:.................................................................................................................. 14
IPQC Test for Tablets ................................................................................................................... 15
Finished good testing:................................................................................................................... 15
Microbiology section of QC: ........................................................................................................ 16
QUALITY ASSURANCE DEPARTMENT............................................................................................ 17
In Production dept:........................................................................................................................ 17
IN RND dept:................................................................................................................................ 18
IN QC:........................................................................................................................................... 18
FG Warehouse............................................................................................................................... 18
3
INTRODUCTION
Schazoo Zaka is one of the fastest growing pharmaceutical
company with more than 51 years of manufacturing and
marketing experience. It is an experienced contract manufacturer
that operates according to the ISO 9001, ISO 14001, cGMP, GLP,
and WHO standards. It has evolved into a diversified health care
company that discovers, develops, manufactures and markets
innovative products that span the continuum of care from
prevention to treatment and cure. Schazoo Zaka has a highly
qualified and appropriately trained team of pharmacists, chemists,
M-Phil's, and marketers. Currently over 450 employees across the
nation have devoted their careers to advancing the practice of
health care. Schazoo Zaka prides on its talented employees who
have shared the commitment of achieving their ambitious mission
by developing leading-edge science and delivering the highest
quality in every product. As such, Schazoo Zaka also prides itself
on providing superior benefits, workplace diversity and vast
training and development opportunities across the company.
4
Products
These are following few products of SCHAZOO ZAKA Pharmaceutical:
1) Eslopress Tablets
2) Joint Care Tablets
3) Rifapin –H dry suspension
4) Rifa 4+ tablets
5) Rifazol junior sachet
6) Cyclosen capsules
7) Piofittablets
8) Nopain tablets
9) Moxizab tablets
10) Ethomid tablets
11) Neobutinol 20 mg tablets
12) Zoprol capsules
13) Zexam 20 mg capsules
14) D-Zak 50
5
DEPARTMENTS OF INDUSTRY:
The Company is involved in the manufacturing of almost all segments
of products having its independent manufacturing sections which are
controlled with centrally air-handling system. There are following main
departments of Schazoo Zaka Pharmaceutical.
WARE HOUSE
It receives raw material. Until this material is cleared it is remains there.
Temperature and humidity are kept under control. From warehouse sample of
coming material is sent to QC for testing, which gives the approval for release of
material for production or reject the material
SUBAREAS:
a) Docking area
b) Quarantine area
c) Dedusting area
d) Storage area
e) Sampling area
f) Dispensing area
1) Docking area:
In docking area material is received from the vendors
2) Quarantine area:
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
6
use by our "quality control laboratory". The sampling is performed according to
specific procedures by trained personnel.
✓ Yellow ribbon shows the quarantine material.
✓ Blue ribbons show the sampled material.
✓ Red ribbons show the rejected material.
✓ Green ribbons show released material.
3) Dedusting Area:
Received material is de dusted in this area,
4) Storage area:
Storing areas divided into three portions based on temperature and humidity of
that area.
1. Main Hall (temperature below 300
C)
2. AC room (temperature below 250
C)
3. Cold room (temperature 2-80
C)
5) 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 personnel
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
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 production department. The
copy of the manufacturing order is kept by the Assistant Store Manager for
record and another copy is given to production pharmacist.
7
Equipment’s:
Equipment available in RM/PM ware house are:
1. Calibrated weighing balance
2. HVAC system
3. Hygrometer
4. Laminar flow hood
5. Pallet lifter
6. Loader
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.
Production area is divided into two sections:
1. Solid antibiotics
2. Solid general
8
1.SOLID ANTIBIOTICS
Solid antibiotic section is specified for rifampicin containing products. These
rifampicin containing antibiotics are used for Tuberculosis.
Dosage forms:
• Tablets, dry suspension, sachet
Equipment’s:
1) 30 BV Grinder:
30 BV grinder is used for the grinding of sugar which is used in dry powder
suspension.
2) Sigma mixer:
Sigma mixer is used for the initial mixing and final mixing of different powders
used in rifa products.
3) Bin blender:
It is used for mixing, and operated on auto mode and on setting menu mode.
4) FZB-Granulator:
• Use for sieving
• Appropriate sieve size (4,12) is used for sieving
5) Roller compactor machine:
Compactor machine is used for compaction of powder material in the form of
flakes. only dry granulation is performed in this section.
• Sieve size used is 12
• It has following parts
➢ Hopper
➢ Horizontal and vertical gauge
9
➢ Roller
➢ Cutter
6) Rotary compression machine:(ZP-29)
• It is used for compression of tablets into desired shape.
• It has dies and 29 upper and 29 lower punches
• After adjusting punches machine is run for 10 minutes to check the
smoothness of machine.
• Normal output of tablets is 25000-45000
7) Coating pan:
Only film coating is done in solid antibiotic section.
It has following parts
• Pressure gauge
• Blower
• LG pump
• Control panel
Rifa Packaging:
• This section is specifically designed for online packing and printing.
There are two types of packaging material
→ Primary packaging material
→ Secondary packaging material
10
2.SOLID GENERAL
This section is specially designed for making the different solid dosage forms like
no pain tablets, capsule tablets etc.
Instrumentation:
• Mixers include (Sigma mixer, Bin blender)
• Granulator → (wet granulator and dry granulator)
• Oscillating granulator
• Roller compactor
• Rotary compression machine ZP-29 & ZP-35
• Coating machines (coating pan, thiocota)
• Sachet filling &sealing machine
• Leakage tester
• Friability tester
• Hardness tester
• Weighing balance
• Friability tester:
o It is used to check the friability of tablets.
o Speed is 25 rev/min
o Total rev performed is about 100
o Limit is 1%
o Friability =
initial wt−final wt
initial wt
(100)
• Hardness tester:
o It is used for testing the hardness of tablet.
Solid General Packaging:
• This section is specifically designed for both online and offline packing and
printing.
There are two types of packaging material
→ Primary packaging material
11
→ Secondary packaging material
QUALITY CONTROL DEPARTMENT
The quality control department 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 are 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 product is rejected and the information is submitted to the
research and development group for evaluation and further disposition. Samples of
finished, packaged product are tested for stability to allow for determination of
expiration dating. Accelerated stability testing as well as real time stability testing is
done 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
shareholders.
• 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.
12
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 SCAZOO ZAKA 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.
13
FLOW CHART OF Q.C
Raw Material Inspection
Raw Material
Receipt
Verification
Sampling
Under Test
Q.C Testing
approved rejected
For manufacturing Return to supplier/Destruction
14
Quality Control test for material by Q.C
department:
For different materials and dosage form different 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
➢ Description or Physical appearance (crystalline, powder, smell, color,)
➢ Solubility (solubility is check by dissolving in alcohol, chloroform or in
water if substance organic in nature and non-polar will dissolve in alcohol
and chloroform and if substance is inorganic and 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 (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)
➢ LOD/ Loss on Drying
Wt. of empty Petri-dish = A
Wt. of Petri-dish + Sample = B
Wt. of sample = B-A = C
After drying at 105C® for 30 minutes wt. of Petri-dish + sample = D
Difference between wt. before drying and after drying = B-D = E
15
% 𝐿𝑂𝐷 =
Diffrence
Wt. of Sample
x 100
=
E
c
x 100 = E
IPQC Test for Tablets
For finished product following test are performed
➢ Description or Physical appearance (crystalline, powder, smell, color,
size, shape)
➢ Identification (identified by using FTIR, TLC, UV spectrometer)
➢ 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
➢ Direct loss test
For bulk only assay is performed to check its percentage purity
Finished good testing:
It includes
✓ Assay
✓ Hardness
✓ Thickness
✓ dissolution
16
Microbiology section of QC:
Microbiology section of QC has following equipment’s:
• Autoclave
• Hot air sterilization cabinet
• Cool incubator having temperature 22 degree Celsius
• Fridge (to store chemical reagents of LAL test)
• Deep freezer
• Laser dust particle counter
Equipment’s:
• HPLC
• UV spectrophotometer
• FTIR
• Dissolution tester
• Disintegration tester
• Filtration assembly
• Karl fisher
• Hot plate
• Sonicator
• Moisture analyzer
• PH meter
• Weigh balance
• Polarimeter
• Melting point apparatus
• Viscometer
• Density tester
• Centrifuge
• Hardness tester
• Potentiometer
17
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.
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 product batch No. packing procedure,
product labeling)
• Stability testing
• Maintain record
• Dispatch testing
• Handling of market complains
• Dispensing checking
• In-process testing
• SOP designing
• Worker’s training
• Validation
• Self-inspection / internal audit
Role in different departments:
In Production dept:
Daily monitoring during the production of products.
18
IN RND dept:
Checking the SOPs and product literature
IN QC:
Daily monitoring
In PM/RM warehouse:
Verify dispensing of material
FG Warehouse
Verify the final material packaging and product before it is going to the market the
final product is store FG warehouse in quarantine area until the receiving of Release
stickers from Q.A department. After receiving of stickers, the final products are from
quarantine are to designated location of that product and it is ready for sale according
to FEFO (first expiry first out).

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Internship report

  • 1. Internship Report 7/05/2021 To 17/08/2021 Internship at: SCHAZOO ZAKA PHARMACEUTICALS PVT. LTD Internship by: Muhammad Shahzaib 4th PROF The University of Lahore, Defence road, Lahore
  • 2. 1 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 report. It has been a good experience by taking training in SCHAZOO ZAKA Pharmaceuticals. The whole staff of organization was cooperative and helpful. I am obliged to intend my thanks to all staff members of SCHAZOO ZAKA Pharmaceuticals for extraordinary guidance and tremendous cooperation throughout the tenure of internship.
  • 3. 2 Contents INTRODUCTION.............................................................................................................................................3 Products .......................................................................................................................................... 4 DEPARTMENTS OF INDUSTRY:........................................................................................................ 5 WARE HOUSE .................................................................................................................................. 5 SUBAREAS:.................................................................................................................................. 5 Dispensing area.......................................................................................................................... 6 ISSUANCE OF RAW MATERIAL: .................................................................................................. 6 Equipment’s:............................................................................................................................... 7 PRODUCTION AREA......................................................................................................................... 7 1. SOLID ANTIBIOTICS.............................................................................................................. 8 2. SOLID GENERAL ................................................................................................................. 10 QUALITY CONTROL DEPARTMENT................................................................................................ 11 Quality Control test for material by Q.C department: .................................................................. 14 Test for Raw Material:.................................................................................................................. 14 IPQC Test for Tablets ................................................................................................................... 15 Finished good testing:................................................................................................................... 15 Microbiology section of QC: ........................................................................................................ 16 QUALITY ASSURANCE DEPARTMENT............................................................................................ 17 In Production dept:........................................................................................................................ 17 IN RND dept:................................................................................................................................ 18 IN QC:........................................................................................................................................... 18 FG Warehouse............................................................................................................................... 18
  • 4. 3 INTRODUCTION Schazoo Zaka is one of the fastest growing pharmaceutical company with more than 51 years of manufacturing and marketing experience. It is an experienced contract manufacturer that operates according to the ISO 9001, ISO 14001, cGMP, GLP, and WHO standards. It has evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products that span the continuum of care from prevention to treatment and cure. Schazoo Zaka has a highly qualified and appropriately trained team of pharmacists, chemists, M-Phil's, and marketers. Currently over 450 employees across the nation have devoted their careers to advancing the practice of health care. Schazoo Zaka prides on its talented employees who have shared the commitment of achieving their ambitious mission by developing leading-edge science and delivering the highest quality in every product. As such, Schazoo Zaka also prides itself on providing superior benefits, workplace diversity and vast training and development opportunities across the company.
  • 5. 4 Products These are following few products of SCHAZOO ZAKA Pharmaceutical: 1) Eslopress Tablets 2) Joint Care Tablets 3) Rifapin –H dry suspension 4) Rifa 4+ tablets 5) Rifazol junior sachet 6) Cyclosen capsules 7) Piofittablets 8) Nopain tablets 9) Moxizab tablets 10) Ethomid tablets 11) Neobutinol 20 mg tablets 12) Zoprol capsules 13) Zexam 20 mg capsules 14) D-Zak 50
  • 6. 5 DEPARTMENTS OF INDUSTRY: The Company is involved in the manufacturing of almost all segments of products having its independent manufacturing sections which are controlled with centrally air-handling system. There are following main departments of Schazoo Zaka Pharmaceutical. WARE HOUSE It receives raw material. Until this material is cleared it is remains there. Temperature and humidity are kept under control. From warehouse sample of coming material is sent to QC for testing, which gives the approval for release of material for production or reject the material SUBAREAS: a) Docking area b) Quarantine area c) Dedusting area d) Storage area e) Sampling area f) Dispensing area 1) Docking area: In docking area material is received from the vendors 2) Quarantine area: 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
  • 7. 6 use by our "quality control laboratory". The sampling is performed according to specific procedures by trained personnel. ✓ Yellow ribbon shows the quarantine material. ✓ Blue ribbons show the sampled material. ✓ Red ribbons show the rejected material. ✓ Green ribbons show released material. 3) Dedusting Area: Received material is de dusted in this area, 4) Storage area: Storing areas divided into three portions based on temperature and humidity of that area. 1. Main Hall (temperature below 300 C) 2. AC room (temperature below 250 C) 3. Cold room (temperature 2-80 C) 5) 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 personnel 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 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 production department. The copy of the manufacturing order is kept by the Assistant Store Manager for record and another copy is given to production pharmacist.
  • 8. 7 Equipment’s: Equipment available in RM/PM ware house are: 1. Calibrated weighing balance 2. HVAC system 3. Hygrometer 4. Laminar flow hood 5. Pallet lifter 6. Loader 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. Production area is divided into two sections: 1. Solid antibiotics 2. Solid general
  • 9. 8 1.SOLID ANTIBIOTICS Solid antibiotic section is specified for rifampicin containing products. These rifampicin containing antibiotics are used for Tuberculosis. Dosage forms: • Tablets, dry suspension, sachet Equipment’s: 1) 30 BV Grinder: 30 BV grinder is used for the grinding of sugar which is used in dry powder suspension. 2) Sigma mixer: Sigma mixer is used for the initial mixing and final mixing of different powders used in rifa products. 3) Bin blender: It is used for mixing, and operated on auto mode and on setting menu mode. 4) FZB-Granulator: • Use for sieving • Appropriate sieve size (4,12) is used for sieving 5) Roller compactor machine: Compactor machine is used for compaction of powder material in the form of flakes. only dry granulation is performed in this section. • Sieve size used is 12 • It has following parts ➢ Hopper ➢ Horizontal and vertical gauge
  • 10. 9 ➢ Roller ➢ Cutter 6) Rotary compression machine:(ZP-29) • It is used for compression of tablets into desired shape. • It has dies and 29 upper and 29 lower punches • After adjusting punches machine is run for 10 minutes to check the smoothness of machine. • Normal output of tablets is 25000-45000 7) Coating pan: Only film coating is done in solid antibiotic section. It has following parts • Pressure gauge • Blower • LG pump • Control panel Rifa Packaging: • This section is specifically designed for online packing and printing. There are two types of packaging material → Primary packaging material → Secondary packaging material
  • 11. 10 2.SOLID GENERAL This section is specially designed for making the different solid dosage forms like no pain tablets, capsule tablets etc. Instrumentation: • Mixers include (Sigma mixer, Bin blender) • Granulator → (wet granulator and dry granulator) • Oscillating granulator • Roller compactor • Rotary compression machine ZP-29 & ZP-35 • Coating machines (coating pan, thiocota) • Sachet filling &sealing machine • Leakage tester • Friability tester • Hardness tester • Weighing balance • Friability tester: o It is used to check the friability of tablets. o Speed is 25 rev/min o Total rev performed is about 100 o Limit is 1% o Friability = initial wt−final wt initial wt (100) • Hardness tester: o It is used for testing the hardness of tablet. Solid General Packaging: • This section is specifically designed for both online and offline packing and printing. There are two types of packaging material → Primary packaging material
  • 12. 11 → Secondary packaging material QUALITY CONTROL DEPARTMENT The quality control department 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 are 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 product is rejected and the information is submitted to the research and development group for evaluation and further disposition. Samples of finished, packaged product are tested for stability to allow for determination of expiration dating. Accelerated stability testing as well as real time stability testing is done 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 shareholders. • 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.
  • 13. 12 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 SCAZOO ZAKA 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.
  • 14. 13 FLOW CHART OF Q.C Raw Material Inspection Raw Material Receipt Verification Sampling Under Test Q.C Testing approved rejected For manufacturing Return to supplier/Destruction
  • 15. 14 Quality Control test for material by Q.C department: For different materials and dosage form different 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 ➢ Description or Physical appearance (crystalline, powder, smell, color,) ➢ Solubility (solubility is check by dissolving in alcohol, chloroform or in water if substance organic in nature and non-polar will dissolve in alcohol and chloroform and if substance is inorganic and 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 (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) ➢ LOD/ Loss on Drying Wt. of empty Petri-dish = A Wt. of Petri-dish + Sample = B Wt. of sample = B-A = C After drying at 105C® for 30 minutes wt. of Petri-dish + sample = D Difference between wt. before drying and after drying = B-D = E
  • 16. 15 % 𝐿𝑂𝐷 = Diffrence Wt. of Sample x 100 = E c x 100 = E IPQC Test for Tablets For finished product following test are performed ➢ Description or Physical appearance (crystalline, powder, smell, color, size, shape) ➢ Identification (identified by using FTIR, TLC, UV spectrometer) ➢ 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 ➢ Direct loss test For bulk only assay is performed to check its percentage purity Finished good testing: It includes ✓ Assay ✓ Hardness ✓ Thickness ✓ dissolution
  • 17. 16 Microbiology section of QC: Microbiology section of QC has following equipment’s: • Autoclave • Hot air sterilization cabinet • Cool incubator having temperature 22 degree Celsius • Fridge (to store chemical reagents of LAL test) • Deep freezer • Laser dust particle counter Equipment’s: • HPLC • UV spectrophotometer • FTIR • Dissolution tester • Disintegration tester • Filtration assembly • Karl fisher • Hot plate • Sonicator • Moisture analyzer • PH meter • Weigh balance • Polarimeter • Melting point apparatus • Viscometer • Density tester • Centrifuge • Hardness tester • Potentiometer
  • 18. 17 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. 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 product batch No. packing procedure, product labeling) • Stability testing • Maintain record • Dispatch testing • Handling of market complains • Dispensing checking • In-process testing • SOP designing • Worker’s training • Validation • Self-inspection / internal audit Role in different departments: In Production dept: Daily monitoring during the production of products.
  • 19. 18 IN RND dept: Checking the SOPs and product literature IN QC: Daily monitoring In PM/RM warehouse: Verify dispensing of material FG Warehouse Verify the final material packaging and product before it is going to the market the final product is store FG warehouse in quarantine area until the receiving of Release stickers from Q.A department. After receiving of stickers, the final products are from quarantine are to designated location of that product and it is ready for sale according to FEFO (first expiry first out).