UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
Drug & Cosmetic ACT 1940 & Rules 1945 unit I.pptxGayatriBahatkar1
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Drug & Cosmetic ACT 1940 & Rules 1945 unit I.pptxGayatriBahatkar1
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
objective, definition, IAEC, CPCSEA guidelines for breeding & stocking of animals, transfer of acquisition of animals for expt., power to suspect or revoke registration, offences & penalties.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
This presentation contains detailed information about administrative bodies set up under the drugs and cosmetics act. The administrative bodies include Drug Technical Advisory Board, Central Drugs Laboratory, Drug Consultative Committee, Government Drug Analysts, Licensing Authorities, Controlling Authorities, and Drug Inspectors.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
This presentation includes an brief idea about the pharmacy act 1948 in India and also deals with its the chapter that included in the act.(Education Regulations, PCI, State PCI, Registration of Pharmacist , Approval of Institutions, Offences penalties etc.)
The Prevention of Cruelty to Animals Act, 1960, authored by acclaimed dancer and animal lover, Rukmini Devi Arundale, is an Act of the Parliament of India enacted in 1960 to prevent the infliction of unnecessary pain or suffering on animals and to amend the laws relating to the prevention of cruelty to animals.
LINK FOR VIDEO LECTURES
https://youtu.be/-4nzP2vOGdg
DRUG TECHNICAL ADVISORY BOARD IS IN THE PHARMACY SYLLABUS AND THE QUESTIONS ARE ASKED IN THE PHARMACY EXAMS .
SUCH AS GPAT NIPER AND SEMSESTER EXAM/
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
This refers to the organization structure, responsibility, procedures, processes and resources needed to implement a comprehensive quality management programme.
It comprises of collective policies, plans, practices and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards and customer expectations in the most cost effective and efficient manner.
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
objective, definition, IAEC, CPCSEA guidelines for breeding & stocking of animals, transfer of acquisition of animals for expt., power to suspect or revoke registration, offences & penalties.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
This presentation contains detailed information about administrative bodies set up under the drugs and cosmetics act. The administrative bodies include Drug Technical Advisory Board, Central Drugs Laboratory, Drug Consultative Committee, Government Drug Analysts, Licensing Authorities, Controlling Authorities, and Drug Inspectors.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
This presentation includes an brief idea about the pharmacy act 1948 in India and also deals with its the chapter that included in the act.(Education Regulations, PCI, State PCI, Registration of Pharmacist , Approval of Institutions, Offences penalties etc.)
The Prevention of Cruelty to Animals Act, 1960, authored by acclaimed dancer and animal lover, Rukmini Devi Arundale, is an Act of the Parliament of India enacted in 1960 to prevent the infliction of unnecessary pain or suffering on animals and to amend the laws relating to the prevention of cruelty to animals.
LINK FOR VIDEO LECTURES
https://youtu.be/-4nzP2vOGdg
DRUG TECHNICAL ADVISORY BOARD IS IN THE PHARMACY SYLLABUS AND THE QUESTIONS ARE ASKED IN THE PHARMACY EXAMS .
SUCH AS GPAT NIPER AND SEMSESTER EXAM/
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
This refers to the organization structure, responsibility, procedures, processes and resources needed to implement a comprehensive quality management programme.
It comprises of collective policies, plans, practices and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards and customer expectations in the most cost effective and efficient manner.
quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:
Quality Assurance and Quality Management System, QUALITY CONTROL
cGMP (GOOD MANUFACTURING PRACTICES
ELEMENTS OF QUALITY MANAGEMENT SYSTEM
PURPOSES OF QUALITY MANAGEMENT SYSTEMS
CONCEPT OF QUALITY ASSURANCE
RESPONSIBILITIES OF QA
GMP COVERS
Quality Management System including the Quality management and certificationAshwiniRaikar1
Concept of Quality, Total Quality Management, Quality by Design, Six Sigma concept, Out of Specification, Change control, Introduction to ISO 9000 Series of quality system standards, ISO 14000,NABL, GLP
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional
Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of
Animals, Performance of Experiments, Transfer and acquisition of animals for
experiment, Records, Power to suspend or revoke registration, Offences and Penalties
NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT 1985 AND.pptxGayatriBahatkar1
Objectives,
Definitions, Authorities and Officers, Constitution and Functions of narcotic &
Psychotropic Consultative Committee, National Fund for Controlling the Drug
Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production
of poppy straw, manufacture, sale and export of opium, Offences and Penalties
Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for
drugs and cosmetics, List of permitted colors. Offences and penalties.
Introduction to Pharmacovigilance
History and development of Pharmacovigilance
Importance of safety monitoring of Medicine
WHO international drug monitoring programme
Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
Definitions and classification of ADRs
Detection and reporting
Methods in Causality assessment
Severity and seriousness assessment
Predictability and preventability assessment
Management of adverse drug reactions
Anatomy of male and female reproductive system, Functions of male and female
reproductive system, sex hormones, physiology of menstruation, fertilization,
spermatogenesis, oogenesis, pregnancy and parturition
Classification of hormones, mechanism of hormone action, structure
and functions of pituitary gland, thyroid gland, parathyroid gland, adrenal gland, pancreas, pineal gland, thymus and their disorders.
Anatomy of urinary tract with special reference to anatomy of kidney and
nephrons, functions of kidney and urinary tract, physiology of urine formation,
micturition reflex and role of kidneys in acid base balance, role of RAS in kidney
and disorders of kidney.
Anatomy of respiratory system with special reference to anatomy of lungs,
mechanism of respiration, regulation of respiration
Lung Volumes and capacities transport of respiratory gases, artificial respiration,
and resuscitation methods.
Energetics
Formation and role of ATP, Creatinine Phosphate and BMR.
References;
Ankur Chaudhari; Pharmaguideline; formation and role of ATP, Creatinine Phosphate; And BMR
https://www.biologyonline.com/tutorials/biological-energy-adp-atp
https://byjus.com/biology/energy-currency-of-the -cell/
https://gbsleiden.com/bioenergetics/
https://www.brainkart.com/article/basal-metabolic-rate-%28BMR%29-the-minimum-energy-expenditure-for-the-body-to-exist_19947/
Anatomy of GI Tract with special reference to anatomy and functions of stomach,
( Acid production in the stomach, regulation of acid production through
parasympathetic nervous system, pepsin role in protein digestion) small intestine
and large intestine, anatomy and functions of salivary glands, pancreas and liver,
movements of GIT, digestion and absorption of nutrients and disorders of GIT.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
2. INDEX
Definition
concept of Quality control
Quality assurance and GMP
Total Quality Management (TQM):
Definition
Elements
Philosophies
3. 1.1 CONCEPT OF QUALITY
The dictionary meaning of 'Quality' is 'the standard of something
when it is compared to other things.
ISO (International Organization for Standardization) defines
quality as 'the totality of features and characteristics of a product
or service that bears on its ability to meet a stated or implied
need.
The meaning of the quality could be understood from two
perspectives: Manufacturer's perspective and Consumer's
perspective.
From the Manufacturer's Perspective, the quality is to conform to
the specifications.
The consumer's perspective is to consider quality characteristics
with price considerations.
Getting maximum quality features while having a price as the
4. Historical Philosophies of
Quality
Walter A. Shewhart, W. Edwards Demin, Joseph M. Juran,
Armand Feigenbaum, Philip Crosby, Genichi Taguchi, Kaoru
Ishikawa have been identified as making a significant
contribution to improving the quality of goods and services. All
these have put their philosophies of quality with some common
points below:
✓ Inspection is never the answer to quality improvement, nor is
"policing".
✓ Involvement of leadership and top management is essential to
the necessary culture of commitment to quality.
✓ A program for quality requires organization-wide efforts and
long term accompanied by the necessary investment in training.
✓ Quality is first and schedules are second.
As per Philip Crosby, Quality is defined as conformance to
requirements, neither a ‘goodness’ nor ‘Elegance’.
5. Crosby’s Five Absolutes of
Quality:
Quality is defined as conformance to
requirements, not as ‘goodness’ or ‘elegance’
There is no such thing as a quality problem.
It is always cheaper to do it right the first time.
The only performance measurement is the cost
of quality.
The only performance standard is zero defects
Crosby suggests that 80 percent of quality
problems are within the control of management.
6. Methods for Quality
Improvement:
Step 1 Establish management commitment.
Step 2 Form quality improvement teams..
Step 3 Establish quality measurements.
Step 4 Evaluate the cost of quality.
Step 5 Raise quality awareness.
Step 6 Take actions to correct problems
Step 7 Zero defects planning.
7. Step 8 Train supervisors and managers.
Step 9 Hold a ‘Zero Defects’ day to establish
the attitude and expectation within the
company.
Step 10 Encourage the setting of goals for
improvement.
Step 11 Obstacle reporting.
Step 12 Recognition for contributors.
Step 13 Establish Quality Councils.
Step 14 Do it all over again.
8. As per Armand V. Feigenboum, Quality is simply a
way of managing a business organization.
Four Steps to Quality:
Step 1 Set quality standards.
Step 2 Appraise conformances to standards.
Step 3 Act when standards are not met.
Step 4 Plan to make improvements.
9. Feigenbaum’s 10 benchmarks for
total quality success:
Quality is a company-wide process.
Quality is what the customer says it is.
Quality and cost are a sum, not a difference.
Quality requires both individual and team zealotry.
Quality is a way of managing.
Quality and innovation are mutually dependent.
Quality is an ethic.
Quality requires continuous improvement.
Quality is the most cost-effective, least capital-intensive
route to productivity.
Quality is implemented with a total system connected
with customers and suppliers.
10. As per Kaoru Ishikawa who is a ‘Father of
Quality Circles’ and as a founder of the
Japanese quality movement quality
approaches include ;
An atmosphere where employees are
continuously looking to resolve problems
Greater commercial awareness;
A change of shop floor attitude is aiming for
ever-increasing goals.
11. Seven tools of Quality control by
Kaoru Ishikawa:
TOOL 1 Pareto charts: Used to identify the principal
causes of problems.
TOOL 2 Ishikawa/fishbone diagrams: Charts of cause
and effect in processes.
TOOL 3 Stratification Layer charts which place each set
of data successively on top of the previous one.
TOOL 4 Check sheets: To provide a record of quality
TOOL 5 Histograms Graphs used to display the
frequency of various ranges of values of quality.
TOOL 6 Scatter graphs Used to help determine whether
there is a correlation between two factors.
TOOL 7 Control charts Used as a device in statistical
Process Control.
12. 1.2 QUALITY ASSURANCE
Quality Assurance (QA) is a management method
that is defined as “all those planned and systematic
actions needed to provide adequate confidence that
a product, service or result will satisfy given
requirements for quality and be fit for use”.
As per WHO (World Health Organization), QA is a
wide-ranging concept consisting all matters that
individually or collectively, directly or indirectly
influence the quality of a product. It is the totality of
the arrangements made with the object of ensuring
that pharmaceutical products are of the quality
required for their intended use. QA, therefore,
Pharmacy incorporates GMP (Good Manufacturing
Practices) and other factors, including product
design and development.
13. Components of Quality Assurance:
Strategic or Organizational Level: This level
deals with the quality policy, objectives and
management and usually produced as the
Quality Manual.
Tactical or Functional Level: This deals with
general practices such as training, facilities,
operation of QA.
Operational Level: This deals with the Standard
Operating Procedures (SOPs), worksheets and
other aspects of day to day operations.
14. Quality Assurance, therefore, incorporates
GMP and other factors such as product
design and development.
Quality Assurance applicable for manufacturing
should ensure that:
All pharmaceutical products developed as per
GMP, GLP (Good Laboratory Practices) and GCP
(Good Clinical Practices) requirements.
Production and control operations comply with
GMP.
Job responsibilities are clearly defined.
Material management and appropriate controls for
the same are in place.
Finished product release is done in compliance
with GMP requirements and with authorized
approvals.
15. Quality of the product is maintained throughout
the shelf life.
Good documentation practices are
implemented and followed.
SOPs for self-inspections, handling deviations,
rejects, recalls etc. are in place.
Investigation processes are followed properly.
Regular evaluation of products is done to
ensure consistent quality products and
continuous improvement.
16. The manufacturer should own the responsibility for the
quality of the pharmaceutical products to ensure that they are
fit for their intended use, comply with the requirements of The
marketing authorization without any adverse or unwanted
reactions on a patient.
Though the senior management is responsible for the
implementation of GMP for attaining good quality products,
commitments from the staff of all levels, suppliers, as well as
distributors, also are also very important aspects.
To achieve the quality objective reliably there must be a
comprehensively designed and correctly implemented
system of quality assurance incorporating GMP and quality
control. It should be fully documented and its effectiveness
17. 1.3 GOOD MANUFACTURING PRACTICES
(GMP) FOR PHARMACEUTICAL PRODUCT
As per WHO, Good manufacturing practice is that part of
quality assurance which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use and as
required by the marketing authorization.
GMP are followed to eliminate the risks associated with
the quality of the product ex. Cross-contaminations, mix-
ups as well as reasons causing the same.
18. A. Clearly defined and systematically
reviewed manufacturing processes:
All batch
documentatio
n
All Quality
specification
All relevant
SOPs
19. B. Critical steps of production processes are
validated:
Process
design
Identification of
process
variables
Control
strategy
Process
qualification
Process
monitoring need
for improvement
PROCESS
VALIDATIO
N
20. C. Appropriate resources: personnel, buildings,
equipment, and materials are available to produce a
quality product: This means that the company has
evaluated all of the elements It needs to produce a
product and has sufficient resources of the right quality
for its production.
D. Manufacturing is based on clearly written
procedures: The procedures referred to here include the
batch manufacturing and testing instructions and the
SOPs needed for every department.
E. Operators are trained: A company can have “all the
documentation in the world” but if its operators are not
properly trained to carry out the tasks that they are
supposed to perform then the company will not be
successful.
21. 1.4 QUALITY CONTROL (QC)
As per WHO, “QC is the part of GMP concerned with sampling,
specifications, testing, organization, documentation and release
procedures which ensure that the necessary and relevant tests
are carried out and that the materials are neither released for
use nor products released for sale or supply until their quality
has been satisfactory. QC is not confined laboratory operations
but must be involved in all decisions concerning the quality of
the product”
Each manufacturing company should have a separate quality
control department.
The independence of quality control from production is
considered fundamental. The quality control department should
be independent of other departments and under the authority of
a person with appropriate qualifications and experience.
22. The QC department must have adequate resources such as
adequate laboratory facilities or access to them e.g. government
or contract laboratories, appropriately qualified, trained and
experienced personnel and approved written procedures ex.
Specifications
QC labs should have minimum following departments:
Chemical testing laboratory with adequate chemicals and
glassware.
Instrument analysis lab with adequate type and number of
analytical instruments.
Microbiology laboratory with facility for microbial testing and
sterility testing it required.
Documentation room.
Retained sample room with suitable environmental
conditions.
23. Components of QC
Department:
QC department is responsible for inspecting, analytical
testing, monitoring of all materials and environmental
conditions in the factory, releasing or rejecting materials
for production use and finished products related to starting
materials, packaging materials, intermediates, bulk
products, and finished products.
Sampling should be undertaken by methods and
personnel approved by the QC department in accordance
with approved SOP. QC personnel must have access to
the production area to undertake to sample when
necessary.
All test methods applied for testing should be validated for
accuracy, precision, linearity, repeatability, robustness,
specificity.
Records for sampling, inspecting, testing of materials,
intermediates and bulk and finished products need to be
kept for traceability.
24. The QC department should review and evaluate the relevant
production documentation in terms of quality. All documents
should be approved by QC to ensure manufacturing
documentation and quality assurance documentation in
harmony.
Records for deviations and failure investigations should be
generated wherever necessary and should be reviewed by the
QC department. Deviations hampering product quality need to
properly investigated and appropriate action needs to be taken.
The finished product should comply with the qualitative and
quantitative composition of the product and should be in
appropriate container closure as mentioned in marketing
authorization.
Assessment of finished products should embrace all relevant
factors, including the production conditions, the results of in-
process testing, the manufacturing (including packing),
documentation, compliance with the specification for the finished
product, and an examination of the finished pack
25. Successful quality control also
requires that:
Materials used for manufacturing are of the
required purity.
Proper containers are used for finished product
packing.
Labeling of in-house materials and the finished
product is correct.
Batches are released by the authorized
person.
Samples of starting materials and products and
retained.
26. In addition to those already mentioned, the
QC department has other duties to carry out,
including:
Establishing, validating and implementing all QC
procedures.
Evaluating, maintaining, storing reference
standards
Ensuring correct labeling of containers of
materials and products.
Stability testing of active ingredients and
finished products.
Participating in complaint investigations.
Participating in environmental monitoring
27. TOTAL QUALITY MANAGEMENT (TQM)
Quality management is defined as “the aspect of
management function that determines and implements the
‘quality policy,’ i.e. the overall intention and direction of an
organization regarding quality, as formally expressed and
authorized by top management”.
Quality cannot be built just by testing, but it should be
ensured at every stage of manufacturing i.e. starting from
purchasing the right material to its manufacturing and
storage. For building quality in product, controls need to be
implemented at each stage related to manufacturing activity.
Below are some basic elements of quality management:
✓ The infrastructure supporting quality management i.e. Quality
system.
✓ Systemic plan and actions to execute planning for
manufacturing quality product.
28. Objectives of Quality
Management
To provide quality medicine.
To minimize defects in product which may lead
to recall or rejection.
To increase productivity keeping quality intact.
To handle all changes in manufacturing facility
without affecting the quality of the product.
29.
30. Quality Management System (QMS) is defined as “the process
of systems of an organization with regard to its quality related
activities for enhancing customer satisfaction and also taking
care of all other interested parties such legislative and regulatory
bodies, shareholders, suppliers, employees etc.”
With the respect to QMS, the ISO 9000 is a family of standards
comprising:
ISO 9000: 2000 provides fundamentals and vocabulary for QMS.
ISO 9001: 2000 introduces QMS and its requirements to address
customer satisfaction.
Provides requirements for compliance with standards.
1S0 9004:2000 provides guidelines for continuous performance
improvements for QMS
ISO 9001: 2000 is the most comprehensive standard in the
series: It specifies system requirements in purchase, design and
development, production, installation and servicing
ISO 9000: 2000 and 1S0 9004 2000 provide guidelines for the
achievement the standards. Certificates to the organizations are
issued based on this standard.
31. Quality Management which is one of the five
sections of ISO 9001: 2000 has below
Objectives:
To consistently meet customer requirements.
To achieve customer satisfaction.
To enhance market share.
To sustain market share.
To improve communications and morale in the
organization.
To reduce costs and liabilities.
To increase confidence in the production system.
32. Total Quality Management
(TQM)
Total quality management (TQM) is a management approach
towards quality for long term success through customer
satisfaction. In a TQM effort, all members of an organization
participate in improving processes, products, services, and
the culture in which they work.
Total Quality Management is mainly concerned with
continuous improvement in all work It is a long term planning.
It is the consistent improvement in quality. It is a never-ending
process.
Total Quality Management consists of three words:
Total: Make up of the whole.
Quality: Degree of excellence a product or service provides.
Management: Process of planning, organizing, directing and
controlling.
33.
34. TQM is relatively new concept of quality control. It is basically,
a management function involving the direction of top
management and co-ordination of all quality-related activities
throughout the company to achieve Zero defects and
customer satisfaction.
Since quality is a measure of the users satisfaction provided
by the product, it should include
Functional efficiency
Appearance.
Ease of installation and operation.
Safety.
Reliability.
Maintainability.
Running and maintenance cost.
In TQM quality awareness begins at the very conception of
the product and continues throughout the various stages of its
development and manufacture and even its usage to provide
feedback from the users which is essential for quality
improvement.
35.
36. Elements of TQM:
Total quality is a description of culture, attitude and organization of a
company that strives to provide customers product and services
that satisfy their needs.
To successful implementation of TQM an organization must
concentrate on 8 key
Elements:
✓ Ethics
✓ Integrity
Trust
Training
Team work
Leadership
✓ Recognitions
✓ Communications
37. TQM Approach:
TQM can be summarized as a management system for a
customer-focused organization that involves all employees in
continual improvement. It uses strategy, data, and effective
communications to integrate the quality discipline into the
culture and activities of the organization.
Below are three major elements for the TQM approach.
Customer-focused: The customer ultimately determines the
level of quality so it is always beneficial to recognize
customer requirements toward product quality.
Total employee involvement: Building quality in product is
not single persons job, all employees should participate in
working toward common goals. Management has to provide a
favorable environment at workplace to achieve every
employee’s commitment towards common goal.
38. Continual improvement: This is very important
and large concept of TOM Continual improvement
drives an organization to become more
competitive and more effective at meeting
customer expectations.
Other than these elements, effective
communication, strategic and systematic
approach facts based decision making also can
be of help for implementing TQM.
Total quality management helps in higher
productivity, strengthening competitive Position,
cost reduction, higher profitability, cost
management, increased customer focus etc. Six
Sigma, ISO 9001, lean manufacturing are some of
the examples of the strategies of TQM.