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QUALITY ASSURANCE,
QUALITY CONTROL AND
TOTAL QUALITY MANAGMENT
Himanshu
Assistant Professor
CONTENTS
1. Quality management in the drug industry
2. Why quality is important in pharmaceuticals?
3. Impacts of ignorance on quality
4. Quality control
5. Role of quality control in pharmaceutical industry
6. Objectives of quality control
7. Components of quality control
8. Functions of qc in pharmaceutical industry
9. Quality assurance
10. Total quality management
11. Characteristics of tqm
12. Benefits of tqm:
QUALITY MANAGEMENT IN THE DRUG INDUSTRY
(WHO)
In the drug industry at large, quality management is usually
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. The basic
elements of quality management are:
an appropriate infrastructure or “quality system”,
encompassing the organizational structure, procedures, processes
and resources; systematic actions necessary to ensure adequate
confidence that a product (or service) will satisfy given
requirements for quality. The totality of these actions is termed
“quality assurance”.
Within an organization, quality assurance serves as a
management tool. In contractual situations, quality
assurance also serves to generate confidence in the
supplier.
The concepts of quality assurance, GMP and quality
control are interrelated aspects of quality management.
They are described here in order to emphasize their
relationship and their fundamental importance to the
production and control of pharmaceutical products
The pharmaceutical environment today is changing quickly due to
globalization, increased competition, cost constraints, demands for
efficiency, development of international regulation, supply chain
complexity, and product/process complexity. In this fast-changing
environment, the people and companies that learn to adapt will
prosper.
To manufacture & deliver consistently zero-defect products to
the patients.
The quality, efficacy and safety attributes of products must be
ensured so that the consumer health is not compromised.
Why Quality is important in pharmaceuticals?
Impacts of ignorance on Quality
MEDICINE
QUALITY
 Manufacturing
process
 Packaging
 Transportation
 Storage
condition  Lack of therapeutic
effect:
 Prolonged illness
 Death
 Toxic and adverse
reaction
 Waste of limited
financial resources
 Loss of credibility
Quality
Assurance
Quality
Quality
Control
QUALITY: A measure of excellence or a state of being free from defects,
deficiencies and significant variations. Quality is “totality of characteristics of
an entity that bear on its ability to satisfy stated and implied needs”. The
ability to make the same thing the same way, over and over again.
QA
GMP
QC
QUALITY CONTROL: Part of GMP concerned with sampling, testing and specifications. OR
Process concerned with medicine sampling, specifications, and testing, and with the organization’s
release procedures that ensure that the necessary tests are carried out and that the materials are not
released for use, nor products released for sale or supply, until their quality has been judged
satisfactory.
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.”
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
OBJECTIVES OF QUALITY CONTROL
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 analyze 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.
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 organization.
COMPONENTS OF QUALITY CONTROL
Adequate facilities, trained personnel and approved procedures must be available
for sampling, inspecting and testing of starting materials, packaging materials and
intermediate bulk and finished products and where appropriate of monitoring
environmental conditions for GMP purpose.
QC LABS
1. Chemical Testing Lab
2. Instrumental Analysis Lab
3.Microbioloy and Toxicology lab
4. Provision for retained samples and stability samples
5. Documentation Room
6. Relevant Books
7. SOPs
8. Trained Personnel
SAMPLING
• Approved method for sampling
• Well trained personnel and sampling tools
• Records maintenance of all sampling
• Checklist for every stage
• Sops divided into – before, during and after
VALIDATION
• All the methods used by QC, say for sampling, testing and other activities
must be validated.
• Validation of testing method is particularly very important.
RECORDS
• Records must be made (manually and/or by recording instrument)
demonstrating that all the required sampling, inspecting, testing procedures
have been actually carried out and that any deviation have been recorded
and investigated.
• Recording is the primary basis of any pharmaceutical activity and hence all
regulations insist on recording of each and every activity carried out. This
helps in tracing the history of a batch produced; this may be required in
future if any investigation is to be made.
• The basic concept of GMP is – Do as you have written (i.e. SOPs) and write
what you have done
FINISHED PRODUCT
The finished product must contain ingredients complying with qualitative and
quantitative composition of the product described in the marketing
authorization, the ingredients must be of required purity, in their proper
containers and correctly labeled.
Preparation of specifications for testing of materials and products.
Carrying out Sampling and testing of materials or products.
Environment Monitoring
Conducting stability studies.
Investigating test failures such as OOS / OOT / OOAC / OOAL.
Analytical method validation.
Evaluation of complaint samples.
All the quality control activities are performed adherence to the GLP
.
Functions of QC in pharmaceutical industry:
Quality Management (QM)
• A quality management system is a management technique
used to communicate to employees what is required to
produce the desired quality of products and services and to
influence employee actions to complete tasks according to the
quality specifications.
• 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.
QUALITY ASSURANCE: Obtaining confidence that, required
quality of product or service is satisfactory for their intended use. OR
Sum of all activities and responsibilities required to ensure that the
medicine that reaches the patient is safe, effective, and acceptable to the
patient.
QA= GMP + QC+ Product design and development + Quality goal
activities
QA is a way of preventing mistakes or defects in manufactured products
and avoiding problems when delivering solutions or services to
customers.
Goals of QA Programs:-
• To make certain that each medicine reaching a patient is safe,
effective, and of standard quality.
• Obtaining quality products that are safe and effective through
structured selection and procurement methods
• Maintaining quality products through the appropriate storage,
distribution, monitoring, and use by prescribers, dispensers, and
consumers
• Characteristics of a QA Program o Medicines are selected on the
basis of safety and efficacy, in an appropriate dosage form with
the longest shelf life.
• Suppliers with acceptable quality standards are selected. o
Medicines received from suppliers and donors are monitored to
meet quality standards.
• Medicine packaging meets contract specifications.
• Repackaging activities and dispensing practices should maintain
quality.
• Adequate storage conditions in all pharmaceutical areas are
maintained.
• Transportation conditions are adequate. o Product quality concerns
are reported and monitored.
ACTIVITIES IN QUALITY ASSURANCE:
1. Planning
2. Data collection
3. Quality control
4. Documentation
5. Evaluation
6. Reporting activities
Total Quality Management
Total - made up of the whole
Quality - degree of excellence a product or service provides
Management - act, art or manner of planning, controlling, directing,….
Therefore, TQM is the art of managing the whole to achieve excellence.
Total Quality Management TQM, also known as total productive maintenance,
describes a management approach to 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 (TQM) has been defined as an integrated
organizational effort designed to improve quality at every level.
The concept of TQM
• Produce quality work the first time.
• Focus on the customer.
• Have a strategic approach to improvement.
• Improve continuously.
• Encourage mutual respect and teamwork.
Characteristics of TQM
Committed management.
Adopting and communicating about total quality management.
Closer customer relations.
Closer provider relations.
Benchmarking.
Increased training.
Open organization
Employee empowerment.
Flexible production.
Process improvements.
Process measuring
Principles of TQM:
Management Commitment
1. Plan (drive, direct)
2. Do (deploy, support, participate)
3. Check (review)
4. Act (recognize, communicate, revise)
Employee Empowerment
1. Training
2. Suggestion scheme
3. Measurement and recognition
4. Excellence teams
Fact Based Decision Making
1. SPC (statistical process control)
2. DOE, FMEA
3. The 7 statistical tools
4. TOPS (Ford 8D – team-oriented problem solving)
Continuous Improvement
1. Systematic measurement and focus on CONQ
2. Excellence teams
3. Cross-functional process management
4. Attain, maintain, improve standards
Customer Focus
1. Supplier partnership
2. Service relationship with internal customers
3. Never compromise quality
4. Customer driven standards
BENEFITS OF TQM:
a) attain higher profitability and increased market share
b) improve customer satisfaction
c) improve organizational productivity
d) improve employee morale and job satisfaction
e) create a positive work culture
f) undertake systematic problem solving and decision making through
project teams
g) improve teamwork
h) create a climate conducive to continuous improvement
THANK YOU

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Introduction qa, qc and tqm

  • 1. QUALITY ASSURANCE, QUALITY CONTROL AND TOTAL QUALITY MANAGMENT Himanshu Assistant Professor
  • 2. CONTENTS 1. Quality management in the drug industry 2. Why quality is important in pharmaceuticals? 3. Impacts of ignorance on quality 4. Quality control 5. Role of quality control in pharmaceutical industry 6. Objectives of quality control 7. Components of quality control 8. Functions of qc in pharmaceutical industry 9. Quality assurance 10. Total quality management 11. Characteristics of tqm 12. Benefits of tqm:
  • 3. QUALITY MANAGEMENT IN THE DRUG INDUSTRY (WHO) In the drug industry at large, quality management is usually 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. The basic elements of quality management are: an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for quality. The totality of these actions is termed “quality assurance”.
  • 4. Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier. The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products
  • 5. The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraints, demands for efficiency, development of international regulation, supply chain complexity, and product/process complexity. In this fast-changing environment, the people and companies that learn to adapt will prosper. To manufacture & deliver consistently zero-defect products to the patients. The quality, efficacy and safety attributes of products must be ensured so that the consumer health is not compromised. Why Quality is important in pharmaceuticals?
  • 6. Impacts of ignorance on Quality MEDICINE QUALITY  Manufacturing process  Packaging  Transportation  Storage condition  Lack of therapeutic effect:  Prolonged illness  Death  Toxic and adverse reaction  Waste of limited financial resources  Loss of credibility
  • 8. QUALITY: A measure of excellence or a state of being free from defects, deficiencies and significant variations. Quality is “totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs”. The ability to make the same thing the same way, over and over again. QA GMP QC
  • 9. QUALITY CONTROL: Part of GMP concerned with sampling, testing and specifications. OR Process concerned with medicine sampling, specifications, and testing, and with the organization’s release procedures that ensure that the necessary tests are carried out and that the materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. 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.”
  • 10. 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
  • 11. OBJECTIVES OF QUALITY CONTROL 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 analyze 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. 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 organization.
  • 12. COMPONENTS OF QUALITY CONTROL Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting and testing of starting materials, packaging materials and intermediate bulk and finished products and where appropriate of monitoring environmental conditions for GMP purpose.
  • 13. QC LABS 1. Chemical Testing Lab 2. Instrumental Analysis Lab 3.Microbioloy and Toxicology lab 4. Provision for retained samples and stability samples 5. Documentation Room 6. Relevant Books 7. SOPs 8. Trained Personnel
  • 14. SAMPLING • Approved method for sampling • Well trained personnel and sampling tools • Records maintenance of all sampling • Checklist for every stage • Sops divided into – before, during and after VALIDATION • All the methods used by QC, say for sampling, testing and other activities must be validated. • Validation of testing method is particularly very important.
  • 15. RECORDS • Records must be made (manually and/or by recording instrument) demonstrating that all the required sampling, inspecting, testing procedures have been actually carried out and that any deviation have been recorded and investigated. • Recording is the primary basis of any pharmaceutical activity and hence all regulations insist on recording of each and every activity carried out. This helps in tracing the history of a batch produced; this may be required in future if any investigation is to be made. • The basic concept of GMP is – Do as you have written (i.e. SOPs) and write what you have done
  • 16. FINISHED PRODUCT The finished product must contain ingredients complying with qualitative and quantitative composition of the product described in the marketing authorization, the ingredients must be of required purity, in their proper containers and correctly labeled.
  • 17. Preparation of specifications for testing of materials and products. Carrying out Sampling and testing of materials or products. Environment Monitoring Conducting stability studies. Investigating test failures such as OOS / OOT / OOAC / OOAL. Analytical method validation. Evaluation of complaint samples. All the quality control activities are performed adherence to the GLP . Functions of QC in pharmaceutical industry:
  • 18. Quality Management (QM) • A quality management system is a management technique used to communicate to employees what is required to produce the desired quality of products and services and to influence employee actions to complete tasks according to the quality specifications. • 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.
  • 19. QUALITY ASSURANCE: Obtaining confidence that, required quality of product or service is satisfactory for their intended use. OR Sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. QA= GMP + QC+ Product design and development + Quality goal activities QA is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers.
  • 20. Goals of QA Programs:- • To make certain that each medicine reaching a patient is safe, effective, and of standard quality. • Obtaining quality products that are safe and effective through structured selection and procurement methods • Maintaining quality products through the appropriate storage, distribution, monitoring, and use by prescribers, dispensers, and consumers • Characteristics of a QA Program o Medicines are selected on the basis of safety and efficacy, in an appropriate dosage form with the longest shelf life.
  • 21. • Suppliers with acceptable quality standards are selected. o Medicines received from suppliers and donors are monitored to meet quality standards. • Medicine packaging meets contract specifications. • Repackaging activities and dispensing practices should maintain quality. • Adequate storage conditions in all pharmaceutical areas are maintained. • Transportation conditions are adequate. o Product quality concerns are reported and monitored.
  • 22. ACTIVITIES IN QUALITY ASSURANCE: 1. Planning 2. Data collection 3. Quality control 4. Documentation 5. Evaluation 6. Reporting activities
  • 23. Total Quality Management Total - made up of the whole Quality - degree of excellence a product or service provides Management - act, art or manner of planning, controlling, directing,…. Therefore, TQM is the art of managing the whole to achieve excellence. Total Quality Management TQM, also known as total productive maintenance, describes a management approach to 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 (TQM) has been defined as an integrated organizational effort designed to improve quality at every level.
  • 24. The concept of TQM • Produce quality work the first time. • Focus on the customer. • Have a strategic approach to improvement. • Improve continuously. • Encourage mutual respect and teamwork.
  • 25. Characteristics of TQM Committed management. Adopting and communicating about total quality management. Closer customer relations. Closer provider relations. Benchmarking. Increased training. Open organization Employee empowerment. Flexible production. Process improvements. Process measuring
  • 26. Principles of TQM: Management Commitment 1. Plan (drive, direct) 2. Do (deploy, support, participate) 3. Check (review) 4. Act (recognize, communicate, revise) Employee Empowerment 1. Training 2. Suggestion scheme 3. Measurement and recognition 4. Excellence teams Fact Based Decision Making 1. SPC (statistical process control) 2. DOE, FMEA 3. The 7 statistical tools 4. TOPS (Ford 8D – team-oriented problem solving)
  • 27. Continuous Improvement 1. Systematic measurement and focus on CONQ 2. Excellence teams 3. Cross-functional process management 4. Attain, maintain, improve standards Customer Focus 1. Supplier partnership 2. Service relationship with internal customers 3. Never compromise quality 4. Customer driven standards
  • 28. BENEFITS OF TQM: a) attain higher profitability and increased market share b) improve customer satisfaction c) improve organizational productivity d) improve employee morale and job satisfaction e) create a positive work culture f) undertake systematic problem solving and decision making through project teams g) improve teamwork h) create a climate conducive to continuous improvement