- The document summarizes the internship of Muhammad Shahzaib at SCHAZOO ZAKA PHARMACEUTICALS PVT. LTD from July 5th to August 17th 2021.
- It describes the various departments within the company including warehousing, production, quality control, and quality assurance.
- The production area is divided into solid antibiotics and solid general sections, and equipment used for manufacturing tablets, capsules, and other solid dosage forms are outlined.
INTERSHIP AT
IPCA LABORATORIES LTD. (KANDLA)
DEDICATION AND WORK TO IPCA
WITH GREAT PLESURE I AM SUBMITTING MY INTERNSHIP REPORT ON QUALITY CONTROLLABORATARIES IN IPCA (KANDLA).
I GOT THE OPPORTUNITY TO WORK AT INDIA’S BEST PHARMACEUTICAL COMPANY
I FOUND THE EXPERIENCE TO BE QUITE INTERESTING AND UNDER THE GUIDANCE OF MY SUPERVISORS AND WITH HELP OF MEMBERS OF THE DEPARTMENT.
I HAVE DEDICATED MY INERNSHIP TO MY TEACHERS WHO FOUND SUCH ABILITY IN ME.
ACKOWLEDGE MENT
KNOWLEDGE HAS NO BOUNDARIES AND THERE IS NO END TO IT. THIS IS WHAT CAME TO MY MIND WHILE PREPARING THIS REPORT.
GOOD EXPERIENCE,TAKING TRAINING IN THE INDIAN PHARMACEUTICAL COMBINE ASSOCIATION LTD. THE WHOLE STAFF WAS COOPERATIVE AND HELPFUL.
I SENCERELY EXPRESS MY THANKS AND GRATITUDE TO THE HONOURABLE QC MANAGER ANAND CHOBEY SIR AND KALPESH SIR WHO PROVIDED ME OPPOERTUNITY OF INTERSHIP AND WORK UNIQUE ORGANISATION.
I AM OBLIGED TO INTEND MY THANKS TO ALL STAFF MEMBERS OF IPCA LTD. FOR EXTRAORDINARY GUIDANCE AND TREMENDOUS COOPERATION THROUGHOUT THE TENURE OF INTERSHIP.
IPCA LABORATORIES
IPCA Laboratories is an international pharmaceutical company based in Mumbai, India. It produces Theo bromine, Acetylthiophene, and P-Bromo Toluene as Active Pharmaceutical Ingredients (APIs). Ipca sells these APIs and their intermediates world over.It produces more than 150 formulations that include oral liquids, tablets, dry powders, and capsules. The various kinds of drug intermediates that the company manufactures include Theo bromine, Acetylthiophene, and P- Bromo Toluene and promotes over 36 countries of Asia, Africa, CIS, and South America, including Cambodia, Kazakhstan, Kenya, Mauritius, Myanmar, Nigeria, Oman, Russia, Sri Lanka, Sudan, Tanzania, Ukraine, Vietnam and Yemen. The main activities of company are to produce and market pharmaceuticals and drugs. The various products of the company include formulations, drug intermediates, and active pharmaceutical ingredients .
INTERSHIP AT
IPCA LABORATORIES LTD. (KANDLA)
DEDICATION AND WORK TO IPCA
WITH GREAT PLESURE I AM SUBMITTING MY INTERNSHIP REPORT ON QUALITY CONTROLLABORATARIES IN IPCA (KANDLA).
I GOT THE OPPORTUNITY TO WORK AT INDIA’S BEST PHARMACEUTICAL COMPANY
I FOUND THE EXPERIENCE TO BE QUITE INTERESTING AND UNDER THE GUIDANCE OF MY SUPERVISORS AND WITH HELP OF MEMBERS OF THE DEPARTMENT.
I HAVE DEDICATED MY INERNSHIP TO MY TEACHERS WHO FOUND SUCH ABILITY IN ME.
ACKOWLEDGE MENT
KNOWLEDGE HAS NO BOUNDARIES AND THERE IS NO END TO IT. THIS IS WHAT CAME TO MY MIND WHILE PREPARING THIS REPORT.
GOOD EXPERIENCE,TAKING TRAINING IN THE INDIAN PHARMACEUTICAL COMBINE ASSOCIATION LTD. THE WHOLE STAFF WAS COOPERATIVE AND HELPFUL.
I SENCERELY EXPRESS MY THANKS AND GRATITUDE TO THE HONOURABLE QC MANAGER ANAND CHOBEY SIR AND KALPESH SIR WHO PROVIDED ME OPPOERTUNITY OF INTERSHIP AND WORK UNIQUE ORGANISATION.
I AM OBLIGED TO INTEND MY THANKS TO ALL STAFF MEMBERS OF IPCA LTD. FOR EXTRAORDINARY GUIDANCE AND TREMENDOUS COOPERATION THROUGHOUT THE TENURE OF INTERSHIP.
IPCA LABORATORIES
IPCA Laboratories is an international pharmaceutical company based in Mumbai, India. It produces Theo bromine, Acetylthiophene, and P-Bromo Toluene as Active Pharmaceutical Ingredients (APIs). Ipca sells these APIs and their intermediates world over.It produces more than 150 formulations that include oral liquids, tablets, dry powders, and capsules. The various kinds of drug intermediates that the company manufactures include Theo bromine, Acetylthiophene, and P- Bromo Toluene and promotes over 36 countries of Asia, Africa, CIS, and South America, including Cambodia, Kazakhstan, Kenya, Mauritius, Myanmar, Nigeria, Oman, Russia, Sri Lanka, Sudan, Tanzania, Ukraine, Vietnam and Yemen. The main activities of company are to produce and market pharmaceuticals and drugs. The various products of the company include formulations, drug intermediates, and active pharmaceutical ingredients .
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guidline.
in plant training at arrow pharmaceuticals pvt ltd, ChagunarayanNeerajOjha17
Arrow Pharmaceuticals Pvt. Ltd was established over 7 years ago under the leadership of now technical director Mahesh Bhatta, a veteran in the field of pharmacy education at institutions like Kathmandu University, with a worldwide level of experience in the field of pharmaceutics. Currently there are over 57 shareholders at Arrow Pharmaceuticals including a local Khadka family which owns several businesses and land all over Kathmandu. Due to involvement of locals at different levels of the company, the industry is well taken care of in terms of emergency and security. Over 1 arab rupees has been spent on the facility.
Arrow is a new pharmaceutical company as compared to many old ones in the same line but is picking up the market and good-will at a great pace. Partnership with other pharmaceutical companies is also taking place at a high speed. Madan Thapa is the chief executive at the marketing department in Basundhara, Kathmandu with national and international connections. Current products by Arrow in the market are helping build the industrial goodwill.
The factory location in the Chagunarayan Municipality is very appropriate in many ways. Very close to the tourist hot spot Nagarkot, it might be a prospective spot of student exchange program or foreign pharmaceutical visiting tourism area in many ways. Nearby nurseries and rice paddies provide a very peaceful background for the busy workers of this company and the visitors.
in plant training at arrow pharmaceuticals pvt ltd BhaktapurNeil Ojha
Arrow Pharmaceuticals Pvt. Ltd was established over 7 years ago under the leadership of now technical director Mahesh Bhatta, a veteran in the field of pharmacy education at institutions like Kathmandu University, with a worldwide level of experience in the field of pharmaceutics. Currently there are over 57 shareholders at Arrow Pharmaceuticals including a local Khadka family which owns several businesses and land all over Kathmandu. Due to involvement of locals at different levels of the company, the industry is well taken care of in terms of emergency and security. Over 1 arab rupees has been spent on the facility.
Arrow is a new pharmaceutical company as compared to many old ones in the same line but is picking up the market and good-will at a great pace. Partnership with other pharmaceutical companies is also taking place at a high speed. Madan Thapa is the chief executive at the marketing department in Basundhara, Kathmandu with national and international connections. Current products by Arrow in the market are helping build the industrial goodwill.
The factory location in the Chagunarayan Municipality is very appropriate in many ways. Very close to the tourist hot spot Nagarkot, it might be a prospective spot of student exchange program or foreign pharmaceutical visiting tourism area in many ways. Nearby nurseries and rice paddies provide a very peaceful background for the busy workers of this company and the visitors.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
Based on Industrial Training internship report in B pharmacy 4th year.
At Roseate Medicare Pharmaceutical Industry Solan.
From Shanti Niketan college of Pharmacy (Malther ,Ratti ,Mandi ,HP 175008)
Sample of a Standard Operating Procedure (SOP) for Cleaning and Sanitizing Ca...NACPT Pharma College
To clean and sanitize the Closed Loop Extraction System in preparation for future runs. This will prevent contamination of future batches and keep gaskets fresh. Cleaning and sanitizing the system will also maintain the equipment, reduce corrosion and degradation of components within the system and protect the longevity of the system for use.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
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.
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).