QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Objective and policies of CGMP and Inventory control . This topic is from M.PHARM 1 st year syllabus from modern pharmaceutics
Objective and policies of CGMP
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
pratik ghive cGMP According to schedule Mpratikghive82
Pratik Ghive Current Good Manufacturing Practices (cGMP) Guidelines According to schedule M Cover all guidelines as per Drug and cosmetic act 1940 and ICH guidelines
GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
GMPs are the requirements that the drug and methods/control /facilities used in their manufacturing, processing and packaging conforms to practice that will assure the safety and efficacy of the product.
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
Similar to Quality control measures in pharmaceutical industry (20)
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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.
Ocular injury ppt Upendra pal optometrist upums saifai etawah
Quality control measures in pharmaceutical industry
1. QUALITY CONTROL MEASURES IN
PHARMACEUTICAL INDUSTRY
PRESENTED BY:
NUPUR
APURVA
PURVA
MAYURI
SHWETA
2. CONTENTS
1. QUALITY CONTROL
2. ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
3. OBJECTIVES OF QUALITY CONTROL
4. STEPS IN QUALITY CONTROL
5. COST OF QUALITY CONTROL
6. TOTAL QUALITY MANAGEMENT
7. QUALITY CIRCLE
2
3. DEFINITION OF QUALITY CONTROL
• Quality as defined by Juran is fitness for purpose or use. It refers
to the features and characteristics of a product that bears on its
ability to satisfy the needs of the consumer. Features like shape,
dimension, composition, strength, workmanship , finish and
colour.
• According to Broom, quality control is “systematic control of
these variables encountered in manufacturing process which
affect the excellence of the end product.”
• According to Alford and Beatty, quality control is “that technique
or group of techniques of industrial management by means of
which products of uniform acceptable quality are manufactured.”
3
4. 4
ATTRIBUTE QUALITY ASSURANCE QUALITY CONTROL
Definition QA is a set of activities for ensuring
quality in the processes by which
products are developed
QC is a set of activities for ensuring
quality in products. The activities focus
on identifying defects in the actual
products produced.
Focus QA aims to prevent defects with a
focus on the process used to make
the product. It is a proactive quality
process.
QC aims to identify (and correct)
defects in the finished product. Quality
control, therefore, is a reactive
process.
Goal The goal of QA is to improve
development and test processes so
that defects do not arise when the
product is being developed.
The goal of QC is to identify defects
after a product is developed and
before it's released.
As a tool QA is a managerial tool,
QA is company based.
QC is a corrective tool,
QC is lab based.
QUALITY ASSURANCE AND QUALITY
CONTROL
5. ROLE OF QUALITY CONTROL IN
PHARMACEUTICAL INDUSTRY
• Quality control is an essential operation of the pharmaceutical
industry.
• Drugs must be marketed as safe and therapeutically active
formulations whose performance is consistent and predictable.
• New and better medicinal agents are being produced at an accelerated
rate. At the same time more exacting and sophisticated analytical
methods are being developed for their evaluation.
• The 4 Main responsibilities of quality control in pharmaceutical
industry include :
Efficacy
Safety
Quality
Compliance
5
6. • Quality Control in the pharmaceutical industry is required for :
Raw Materials and API:
The techniques used include Raman and IR spectroscopy, Assay( HPLC and
Titration ), Physical tests.
Packaging Components :
The various packaging components which are in contact with the drug are
tested. The techniques include appearance, spectroscopy, loss on drying.
Finished Products :
The techniques include HPLC, Assay, Dissolution, Content uniformity.
6
ROLE OF QUALITY CONTROL IN
PHARMACEUTICAL INDUSTRY
7. QUALITY VARIATION
• When the quality of any drug is given by industry, then it is
responsible for any variation from the standard.
• Quality Variation may occur due to any mistake during the whole
process i.e. from the reception of raw material up to the final product
in the packaged form.
• The risk of error increases as the material increases and
the method become very complicated.
7
8. • The general sources causing product Quality Variation during manufacturing are as
follows:
8
QUALITY VARIATION
MATERIALS:
a. Variations among suppliers of same
substances.
b. Variations among batches from same
suppliers.
c. Variations within a batch.
MACHINES:
a. Variation of equipment of same process.
b. Difference in adjustments of equipment.
c. Aging of machines and improper care.
METHODS:
a. Wrong procedure.
b. Inadequate procedure.
c. Negligence in procedure by chance.
MEN:
a. Improper working conditions.
b. Inadequate training and understanding.
c. Lack of interest and emotional
upheavals.
d. Dishonesty, fatigue and carelessness.
SOURCES OF VARIATION
9. QUALITY VARIATION CONTROL
9
• Material control.
Controlling each and every step of process can control variations.
Control can be divided into:
• Manufacturing practice control.
• Packaging control.
• Distribution control.
10. MATERIAL CONTROL:
• It starts just after the reception of materials.
• Most of the materials that are active substances, excipients, packaging and
printed materials are received by the industry from suppliers.
• Thus there should be adequate established system for the receipt, testing and
storage of all these supplies.
• There should be a complete record of all the procedures and tests. In the
material following things are included:
• Drug substances.
• Excipients.
• Packaging and printed materials.
10
QUALITY VARIATION CONTROL
11. • After the reception of material, it is kept in a definite area.
• Thus before laboratory testing, proper containers, labels, lot number,
expiry dates etc all are checked.
• The material is stored in a proper way either they are
arranged alphabetically or they are differentiated depending upon
physical nature.
• Then samples are taken for laboratory testing and a label (Sampled) is
fixed on material.
• In case of active constituents, percentage purity, adulteration, expiry
date, lot number, exact packing etc is checked.
In case of printing and packaging material especially the color of label,
weight of label and cartons and damage etc is checked.
If the material is up to the mark, then a label (Passed) is pasted on it and
it is placed at its proper place.
On the other hand, if it is substandard, then it is kept in “Rejected Area”
and sent back to the supplier.
11
QUALITY VARIATION CONTROL
12. • MANUFACTURING PRACTICES CONTROL:
Successful GMP is difficult to attain but to some extent, it can be modified and controlled.
Specific procedures can be applied to attain the best quality.
In case of manufacturing, following controls are important:
Personnel.
Equipment and building.
Control of record.
Production procedure control.
(A). PERSONNEL:
Usually properly educated and well-trained persons should be in the industry.
There should be proper selection and training in all departments i.e. production,
packaging, labeling, etc, etc.
There should be general lectures for less educated persons who work in the labeling or
packaging section in an understandable language.
They should be made aware of the fact that what is the importance of life saving.
They should be warned about all the dangers of their mistakes and errors.
There should be properly educated supervisors working above the workers.
The supervisors should always be there so that in case of any trouble or question, they
must be available.
All the workers should be properly checked and all the processes at different steps should
also be monitored by highly educated and experience persons who may not only be
well qualified but experienced as well.
12
QUALITY VARIATION CONTROL
13. • (B). EQUIPMENT AND BUILDING:
The equipments and building used in storage, processing, checking and
packaging should be of a suitable design, size, construction and location.
In case of equipments, these should be constructed in a proper size
and proper way. The size should be such that complete batch can be
processed all at once.
The surfaces of equipments should be non-reactive, non-absorptive
and non-additive.
The equipment should be constructed and fitted in such a way that it is
easy to replace, easy to wash easy to operate and easy to empty.
In case of building, there should not be any contamination i.e. the
tablet and liquid section should be separated completely and even there
should be complete separation in tablet machines. It means that
machines should have separate cabinet.
13
QUALITY VARIATION CONTROL
14. • (C) CONTROL OF RECORD:
The records such as master formula record and batch production record must be
maintained.
1. MASTER FORMULA RECORD:
a. The master formula record must be prepared for each product.
b. It must be signed by a competent and responsible person.
c. The language must be so that it may not be miss-interpreted.
d. It should be checked by another competent person and must be
countersigned.
e. The master formula varies from production to production and from batch to
batch.
f. Master formula record include the following information:
i. Name of the product, dosage form and strength.
ii. Complete list of ingredients including excipients.
iii. Quality by weight or volume of each and every ingredient.
iv. Standards or specifications of each ingredient.
v. Any calculated excess of an ingredient.
vi. Theoretical yield and termination of process.
vii. Manufacturing and control instructions, specifications and precautions.
viii. Complete description of closures, containers, labeling, packaging and other
finishing material.
14
QUALITY VARIATION CONTROL
15. • . BATCH PRODUCTION RECORD:
a. Batch production record must be prepared, maintained and controlled for each batch of a product.
b. It must be retained for about 5-years after product distribution.
c. Batch production record should have following information in addition to master formula record.
i. Batch number.
ii. Code number.
iii. Manufacturing date.
iv. Expiry date.
(D). PRODUCTION PROCEDURE CONTROL:
The processes of manufacturing are operated according to the established rules from the reception of
material up to delivery of final product.
A complete list of ingredients along with their quantities is delivered to the Production Department.
It is called Master Formula of that batch. It contains all the information of that batch i.e. procedures
and equipments to be used and precautions to be taken, etc, etc.
This master formula is taken into the store and all the materials for the batch are weighed and
delivered to Production Department. All ingredients are rechecked and tested in laboratory.
In the production procedure control, some tests are done during the process, which is called “In
Process Quality Control (IPQC)”
The IPQC is under Quality Control Department.
Both Quality Control and Production Departments are responsible for the production procedure
control. 15
QUALITY VARIATION CONTROL
16. • PACKAGING CONTROL:
The packaging control is usually completed before manufacturing of
product.
When the product come in packaging section, it should be packed in
recommended containers and there should not be any mistake in case of
labeling and writing of batch number, etc, etc.
The packaging material is used according to the nature and distribution
of product.
DISTRIBUTION CONTROL:
The responsibilities of Quality Control Department are not finished even
after the distribution of finished dosage form in the market.
The samples of each batch are kept in record and these samples are
selected during packaging and are in the same packs as they are
marketed.
These are kept for years in order to examine or test the material for
any purpose or necessary demand.
16
QUALITY VARIATION CONTROL
17. OBJECTIVES OF QUALITY CONTROL
17
Establishment of quality standard:
Main motive of QC is the economical production of a high quality product
at the quality level the customer wants.
Locating quality deviations:
It is necessary to analyse the trend and extent of quality deviations in a
manufacturing process, which should be explained by statistical
techniques.
Evaluating methods and processes of production:
It is a corrective measure to maintain the quality.
18. Quick sale of quality goods
QC accelerates the sale of the goods by supplying only the quality goods.
Production of standard quality goods
QC aim at manufacturing standard quality products and avoids producing
inferior quality goods.
Improvement in quality
Aims at creating quality consciousness at all levels in the organisation.
18
OBJECTIVES OF QUALITY CONTROL
19. STEPS IN QUALITY CONTROL
19
• 1. DEVISING THE CONTROL OVER RAW MATERIALS:
• The quality of the finished products is determined mostly by the quality of raw
materials.
• 2. FIXING STANDARDS AND SPECIFICATIONS:
• In order to make any scheme of quality control successful, it is necessary to
predetermine standards and specifications.
• 3. EXERCISING CONTROL OVER PRODUCTION OPERATIONS:
• In order to execute efficient practices, the technical expert of the Quality Control
Department must investigate the operating methods.
20. • 4. LOCATING INSPECTION POINTS:
• When the points at which defects occur are wrongly located or located with delay,
it hinders quality control. Hence there should first be inspection of raw material at
vendors place, then at company’s plant then at various stages during process.
• 5. MAINTAINING QUALITY OF EQUIPMENTS:
• The final quality of the products is conditioned by the quality of the equipment and
other devices used.
• 6. MAINTAINING RECORDS:
• The QC department is responsible for setting records related to quality inspection
and control and the number rejected
20
STEPS IN QUALITY CONTROL
21. ADVANTAGES OF QUALITY CONTROL
1) Improvement of the quality of production and reduction in the
production cost.
2) Uniformity in the production and supply of standard quality goods to
consumers.
3) Offering full return of the price paid by the consumers and giving
convenience and satisfaction to consumers .
4) Reduction in spoiled production and rejection from consumers and
dealers.
5) Promotion of exports due to superior and standard quality
production.
6) Reduction in inspection cost.
7) Making products popular in market.
21
23. COST OF QUALITY
• The costs of carrying out company quality program are known as Cost of
Quality. It includes –
• Market research cost of discovering quality needs of customer.
• Product research and development cost of creating a product concept,
which will meet quality needs.
• The design cost of transmitting product concept into information which
represents planning for manufacturer.
• Cost of inspection and test.
• Cost of defect prevention.
• Cost of quality assurance.
• Cost of scrap and quality failure.
23
25. COST OF PREVENTION
It consists of costs associated with person engaged in designing,
implementing, maintaining the quality system.
Cost of prevention includes-
• Cost of Quality planning
• Cost of Documenting.
• Process control cost.
• Cost of training.
• Cost associated with preventing recurring defects.
• Cost of investigation, analysis of correction of causes of defects by
quality central department.
• Cost of consciousness programs.
25
26. COST OF APPRAISAL
• The cost of evaluating, quality and of identifying and segregating
non-conforming part and assemblies is called as the cost of appraisal.
This consists of–
• Receiving or incoming tests and inspection.
• Laboratory and acceptance test.
• Inspection and test.
• Checking labor.
• Set up for inspection and test and test material.
• Quality Audits.
• Review of test and inspection data.
• Evaluation of field stocks, spare parts.
26
27. COST OF INTERNAL FAILURE
The costs associated with defective products, components, materials that
fail to meet quality requirements and results in manufacturing losses are
called as cost of internal failures.
These include-
• Costs associated with scrap, cost of material, labor. Cost of rework,
repair i.e. cost of making defective parts and assembly rules.
• Cost of re-inspection and re-test after defective parts are repaired.
• Costs associated with material review activity.
• Cost of processes yield lower that might be attainable by improved
controls.
• Trouble shooting.
27
28. COST OF EXTERNAL FAILURE
This is the cost because of defective products being shifted
to the customer.
It includes-
• Cost of processing complaints from the customer.
• Cost of service to customer to receive defective items.
• Cost of inspecting, preparing defective items.
• Cost of replacing defective products.
28
29. TOTAL QUALITY MANAGEMENT
• According to John Gilbert, Total Quality Management is "A process
designed to focus on customer expectations, preventing problems,
building commitment to quality in the workforce and promoting open
decision-making.“
• It is a comprehensive concept. Not restricted to only goods and services.
• High quality standards should be maintained in other aspects of
management such as production cost, marketing, sales promotion, etc.
• To achieve this quality/efficiency- develop consciousness/awareness
among employees working in all departments of the enterprise.
• Co-operation/involvement is necessary for maintaining efficiency in all
aspects of business management.
29
30. • In brief, quality management is not the responsibility of management
alone.
• Participation/involvement of both parties (management and
employees) is essential for achievement of quality and other
benefits.
30
TOTAL QUALITY MANAGEMENT
32. WHY IS IT NEEDED?
• For consumer satisfaction and pleasure.
• TQM is needed as it suggests progressive philosophy in business, in which
the stress will be on consumer expectations, total commitment to quality
and participative management.
• To face market competition effectively, to create goodwill and to have
support of consumers.
• For lowering rejection rate in production process and also for reducing the
complaints of consumers.
• For motivation of employees and also for giving them better facilities,
training and participation in decision-making.
• To facilitate industrial growth, economic progress and prosperity to the
nation.
32
33. PRINCIPLES OF TQM
Stress on quality management
Continuous process
Stress on quality assurance system
Linkage of quality and productivity
TQM is a gradual process
Focus on customers
Employee involvement
Formation of quality improvement teams
Management's involvement
33
34. 1. Stress on quality management:
• Collective efforts are being made for improving quality of goods and services
to give more satisfaction to consumers.
• Quality improvement is also useful for facing market competition and for
creating market reputation.
• TQM involves steps for improving quality and productivity.
• There is total commitment to quality on the part of entire Organisation.
2. Continuous process:
TQM is a continuous process/activity as there is ample scope for using new
methods and techniques for improvement in the quality standards and
performance.
Implementation of innovative ideas or taking benefit of new opportunities
is an integral aspect of TQM.
TQM is a never ending quest for achieving new levels of performance.
34
PRINCIPLES OF TQM
35. 3. Stress on quality assurance system:
• The aim of TQM is to give maximum satisfaction to consumers by providing goods
which are best in quality (zero defects).
• The present ISO9000 series is a set of well recognised standards for quality
assurance system.
• The Japanese have been using quality assurance concepts and principles as a part
of their TQM implementation programme even when specific name or number
was not used.
• Thus, quality assurance system is an integral part of TQM.
4. Linkage of quality and productivity:
• The methods used in TQM programmes E.g. stress on quality improvement, zero
defects production, making all employees responsible for quality maintenance and
improvement) are likely to bring quality improvement as well as yield
improvement.
• Similarly, the TQM programme creates a feeling of participation among the
employees.
• There is also positive improvement in the morale of employees. 35
PRINCIPLES OF TQM
36. 5. TQM is a gradual process:
• It includes self improvement and group improvement programme through team building
for raising quality and productivity.
• TQM is about the gradual change of people's behavior towards the tasks they perform and
their attitude towards other people.
• A mental revolution among the employees is required for the execution of TQM.
• However, such change in the mental make-up of managers and employees requires long
period. This suggests that TQM is a gradual process. There are, in fact, four broad phases in
the introduction of TQM. These are: (a) Awareness Phase, (b) Planning Phase, (c)
Implementation Phase, and (d) Institutional Phase.
6. Focus on customers:
• Customers are the source of all the revenue that flows through the corporation.
• Their satisfaction keeps the money flowing especially in an open market where competitors
are pursuing them too.
• The focus of TQM is on customer satisfaction on quality, cost and delivery through
improved orgarnisational quality of processes.
• According to British Quality Association (BQA), TQM is a corporate business management
philosophy which recognised that customers' needs and business goals are inseparable.
36
PRINCIPLES OF TQM
37. 7. Employee involvement:
• Their participation and co-operation are required to be taken at all levels.
• TQM is possible only through participative management.
• Under TQM, employees will be motivated to participate actively in the process of
quality improvement through incentives and recognition of contribution for
achieving quality standards.
8. Formation of quality improvement teams:
• A cornerstone of TQM is the team building that leads to commitment to
improvement.
• Such teams include quality steering teams, corrective actions teams and so on.
Such teams motivate employees and facilitate quality improvement.
9. Management's involvement:
• TQM is a systems approach in managing business and improving overall
performance.
• It needs total commitment from the top management to provide viable leadership
to the whole approach.
• Top level management has to take number of initiatives in order to start the
process of TQM. In fact, TQM cannot have a good take off without total
commitment of CEO and other senior executives.
37
PRINCIPLES OF TQM
38. ADVANTAGES OF TQM
• Customer satisfaction
• Quality improvement
• Absence of additional investment
• Raises competitiveness
• Facilitates expansion and diversification
• Provides trained and motivated employees
• Miscellaneous Advantages
• (a) Long-term consumer support,
• (b) Prestigious position in international marketing,
• (c) High standard of living to employees, and
• (d) Cost control.
38
39. QUALITY CIRCLE
It is defined as a way of capturing the creative and innovative power that
lies within the work force.
A Quality Circle is a small group of volunteers doing similar work.
They meet regularly under the leadership of their immediate supervisor
to-
Identify problems.
Set priorities.
Discover causes.
Propose solutions.
39
40. The problems may concern-
Quality.
Productivity
Safety
Job structure
Process flow
Thus Quality Circle is a participative management system in which
workers make suggestions and improvements for the betterment of
organization.
40
QUALITY CIRCLE
41. CONCEPT OF QUALITY CIRCLE
It consists of the following attributes:
1. QC is a form of participative management.
2. QC is a human resource development technique.
3. QC is a problem solving technique.
41
42. OBJECTIVES OF QUALITY CIRCLE
1. To improve quality and productivity.
2. To reduce cost of products/services.
3. To identify and solve problems.
4. To tap intelligence of workers.
5. To develop and motivate employees.
6. To improve communication within organization.
7. To increase employees loyalty and commitment.
8. To respect humanity and make work place happy.
9. To enrich human capability, confidence, moral, attitude and
relationships.
10. To satisfy human needs
42
43. ADVANTAGES OF QUALITY CIRCLE
1. Promote productivity and quality mindedness.
2. Development of employees.
3. Creating team spirit and unity of action.
4. Increased motivation, job satisfaction and pride in work.
5. Reduced absenteeism and labor turnover.
6. Developing sense of belongingness towards organization.
7. Waste reduction.
8. Cost reduction
9. Improved communication.
10. Safety improvement
11. Increased human resource potential.
12. Increased consciousness and moral of employees.
13. Leadership development.
14. Trained staff.
43