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Quality Assurance
&
Quality Control:
In Pharmaceuticals &
Healthcare Industries.
Presented by: Naman Gupta
B.Pharmacy
MVN University
“Quality is never an accident;
it is always the result of high intention,
sincere effort, intelligent direction, and skillful execution;
it represents the wise choice of many alternatives.”
-William A. Foster.
Why Quality is important in pharmaceuticals?
 The pharmaceutical environment today is changing quickly due to globalization,
increased competition, cost constraints, demands for efficiency, development of
international regulations, supply chain complexity and product/process complexity.
In this fast-changing time 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 be compromised.
Impacts of ignorance on Quality.
• Manufacturing
process.
• Packaging.
• Transportation.
• Storage condition.
MEDICINE
QUALITY
• Lack of
therapeutic
effect:
- Prolonged
illness.
- Death.
• Toxics &
adverse
reaction.
• Waste of
limited
financial
resources.
• Loss of
credibility.
 QUALITY: A measure of excellence or a state of being free from
detects, deficiencies and significant variations.
 QUALITY ASSURANCE: Obtaining confidence that, required quality of
product or service is satisfactory for their intended use.
 QUALITY CONTROL: Part of the GMP concerned with the sampling,
testing and the specifications.
Quality Culture
 Support for the Quality Organization.
 Actions More than Words.
 Investment in Quality.
 Quality involved in Relevant Business Decisions.
 The Quality of the Work You Accept Becomes the
Organization’s Standards.
 Organizational Structure:
- Assures that Quality is independent and not subordinate to
other organizational unit.
Quality Responsibility
Quality is the collective responsibility of every individuals in an
Organization.
It is a well known belief that the quality initiatives are
successful only when it is driven from the top management
to the lower levels of the management.
Quality must be Designed into a
Product
Quality by design (QbD approach)
 Quality is not an add-on: it begins with research
and development.
 Product quality criteria must be established.
 Detailed specifications provide quantitative
parameters for measurement.
 Written procedures document how quality is
attained and maintained.
 Continuous monitoring (sampling, testing) to
confirm quality is being built-into product.
Functions of QA in Pharmaceutical industry
To ensure:
 Raw materials used in the manufacturing are approved and produced from
approved vendor.
 All datas are recorded as per cGMP and is reviewed for accuracy and
traceability.
 Procedures are in place for performing the activities, operating and
calibrating the equipment.
 Quality is built up in the plant, process, product. That a Robust Quality system
is in place.
 Trainings like induction, on job, Scheduled and after any changes are
conducted to respective individuals on time.
Functions of QA in Pharmaceutical industry
 To prepare and approve Quality Policy, Quality Objectives, Quality Manual,
and Validation Master Plan.
 Periodic Monitoring of the Quality Objectives.
 Monitors all validation & stability activities are completed as per the
schedule.
 Ensures that all changes impacting the product and the established systems,
are documented and reviewed to analyze the impact.
 Ensures that all derivations, OOS/OOT & Market complaints are logged,
investigated to identify the root cause so as to take CAPA to prevent
recurrence.
 Preparation of Annual product quality reports, trending of data, determining
product and process performance.
 To arrange and conduct the self inspection, identify gaps, and take CAPA.
 Review of related batch manufacturing records and QC testing data Prior to
release of the any batch.
QUALITY CONTROL
Qc is the part of GMP concerned with the
sampling, specifications, and the testing and
with the organization, documentation and
release procedures which ensures that the
necessary and relevant tests are actually carried
out and the materials are neither released for
use, nor products are used for sale and supply
until their quality has been satisfactory.
QUALITY CONTROL LABS
 Preparation of the specifications for testing of the materials and the products.
 Carrying out Sampling and testing of materials or the products.
 Environment Monitoring.
 Conducting stability studies.
 Investigating test failures such as OOS/ OOT/ OOAC/ OOAL.
 Analytical method validation.
 Evaluation of complaint samples.
- All the quantity control activities are performed adherence to the GLP.
QUALITY METRICS:
A tool (ISPE: International Standards for Pharmaceutical Engineers)
for continuous improvement in Quality.
- It is a measurement standard by which efficiency, performance, progress
compliance or quality of a process, or product can be assessed.
1. KPI’S shall be identified based on impact on organization goals and quality.
2. Weightage to be provided for each KPI.
3. Scoring to be provided for each KPI based on actual performance.
4. Communication to top management.
5. Necessary developments to be made to improve the failed KPI.
-> e.g. of KPI- Batch failures, Market complaint, deviations, Changes, OOS, Stability
Overdue, RM/PM/FG release time.
QUALITY ASSURANCE
“ Planned and systematic activities implemented within the
quality system that can be demonstrated to provide
confidence that a product or service will fulfill
requirements for the quality”.
-Quality Assurance is a system for evaluating performance, service,
of the quality of a product against system, standard or specified
requirement for customers.
OBJECTIVE OF QA(Quality Assurance)-
1. Managing good manufacturing practices (GMP) including.
2. Managing good laboratory practices (GLP).
3. Managing a safety programme.
4. Assuring the quality of raw materials.
5. Assuring the quality and traceability of finished product.
6. Evaluating plant environment.
7. Developing an HACCP plan.
FUNCTIONS OF QUALITY ASSURANCE:-
1. To maintain standards & specification for all the raw materials & finished
products.
2. To give service to the company in all areas related to the product quality
includes trouble shooting, visiting, production, facilities, designing and training
Quality control panel.
3. To produce information that is accurate, reliable and adequate for the
intended purpose.
4. Evaluating performance, service, of the quality of a product against a system,
standard or specified requirements for costumers.
QUALITY CONTROL
VS
QUALITY ASSURANCE
SCOPE OF QA/QC IN PHARMACEUTICAL
SR
NO.
Criteria Quality Assurance Quality Control
1. Focus To prevents defects with a
focus on the process.
To identify defects in the
finished product.
2. Goal To improve development
and test processes so that
defects do not arise.
To identify defects after
a product is developed
and before it’s released.
3. How Establish a good quality
management system &
assessment of its
adequacy with continuous
monitoring.
Finding sources of quality
problems to continually
meet customer’s
requirement.
SCOPE OF QA/QC in pharmaceutical
SR
NO.
CRITERIA QUALITY
ASSURANCE
QUALITY
CONTROL
4. What Prevention of quality
problems through
planned and systematic
activities.
Analytical techniques used
to maintain the product
quality and process.
5. Responsibility Everyone on the team. Of a specific team that
tests the product for
defects.
6. As a tool QA is a managerial tool. QC is a corrective tool.
GMP(GOOD MANUFACTURING PRACTICES)
-> Good Manufacturing Practice is a set of
regulations, codes, and guidelines for the
manufacture of the drug products, medical
devices, in vivo and in vitro diagnostic
products, and foods.
GENERAL REQUIREMENTS:-
 Avoid risks and possibilities of mix-up at all stages of
Mfg., labelling Pkg and testing.
 AHUs, comfort of the personnel working and the regular
monitoring of the temperature & humidity, Particle
count, DOP testing etc.
 Proper drainage system which prevents backflow. Avoid
open channels and if provided must be able to clean and
disinfect.
COMPONENTS OF THE GOOD MANUFACTURING PRACTICES(GMP)
TEN PRINCIPLES OF GMP
1. Design and construct the facilitates and equipment's properly.
2. Follow written procedures and Instructions.
3. Document work.
4. Validate work.
5. Monitor facilitates and equipment.
6. Write step by step operating procedures and work on the instructions.
7. Design, develop and demonstrate job competence.
8. Protect against contamination.
9. Control components and product related processes.
10. Conduct planned and periodic audits.
GMP GUIDELINES
• GMP as per Schedule ‘M’.
• GMP as per WHO.
• GMP as per MCA now known as MHRA.
• GMP as per TGA.
• GMP as per US FDA.
• GMP as per ICH guidelines.
- WHO:- World Health Organization.
- MHRA:- Ministry of Health and Regulatory Affairs.
- TGA:- Therapeutic Good Affairs.
- FDA:- Food and Drug Administration.
- ICH:- International Conference on Harmonization.
Why GMP is important?
• Avoids poor quality medicines, a health hazards.
• Saves waste of money for both Government and individuals
consumers.
• Helps boost pharmaceutical export opportunities.
• Reduces and prevent errors.
• Prevents contamination & cross contamination.
• Minimize variance in drug potency.
• Prevents toxicity.
• Prevents mislabeling.
• Avoids adulteration.
SOME OF THE MAJOR RISKS ARE:-
 Unexpected contamination of products, causing damage to the
health or even the death.
 Incorrect labels on containers, which could mean that the patients
receive the wrong medicine.
 Insufficient or too much active ingredient, resulting ineffective
treatments or adverse effects.
CONCLUSIONS:
From the above discussion we can conduct that-
1. Pharmaceutical industry is regulated by the GMPs.
2. Good Manufacturing Practices must be followed.
3. GMPs ensure drugs products are safe, pure and effective.
THANK
YOU

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Quality

  • 1. Quality Assurance & Quality Control: In Pharmaceuticals & Healthcare Industries. Presented by: Naman Gupta B.Pharmacy MVN University
  • 2. “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction, and skillful execution; it represents the wise choice of many alternatives.” -William A. Foster.
  • 3. Why Quality is important in pharmaceuticals?  The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraints, demands for efficiency, development of international regulations, supply chain complexity and product/process complexity. In this fast-changing time 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 be compromised.
  • 4. Impacts of ignorance on Quality. • Manufacturing process. • Packaging. • Transportation. • Storage condition. MEDICINE QUALITY • Lack of therapeutic effect: - Prolonged illness. - Death. • Toxics & adverse reaction. • Waste of limited financial resources. • Loss of credibility.
  • 5.
  • 6.  QUALITY: A measure of excellence or a state of being free from detects, deficiencies and significant variations.  QUALITY ASSURANCE: Obtaining confidence that, required quality of product or service is satisfactory for their intended use.  QUALITY CONTROL: Part of the GMP concerned with the sampling, testing and the specifications.
  • 7. Quality Culture  Support for the Quality Organization.  Actions More than Words.  Investment in Quality.  Quality involved in Relevant Business Decisions.  The Quality of the Work You Accept Becomes the Organization’s Standards.  Organizational Structure: - Assures that Quality is independent and not subordinate to other organizational unit.
  • 8. Quality Responsibility Quality is the collective responsibility of every individuals in an Organization. It is a well known belief that the quality initiatives are successful only when it is driven from the top management to the lower levels of the management.
  • 9. Quality must be Designed into a Product Quality by design (QbD approach)  Quality is not an add-on: it begins with research and development.  Product quality criteria must be established.  Detailed specifications provide quantitative parameters for measurement.  Written procedures document how quality is attained and maintained.  Continuous monitoring (sampling, testing) to confirm quality is being built-into product.
  • 10. Functions of QA in Pharmaceutical industry To ensure:  Raw materials used in the manufacturing are approved and produced from approved vendor.  All datas are recorded as per cGMP and is reviewed for accuracy and traceability.  Procedures are in place for performing the activities, operating and calibrating the equipment.  Quality is built up in the plant, process, product. That a Robust Quality system is in place.  Trainings like induction, on job, Scheduled and after any changes are conducted to respective individuals on time.
  • 11. Functions of QA in Pharmaceutical industry  To prepare and approve Quality Policy, Quality Objectives, Quality Manual, and Validation Master Plan.  Periodic Monitoring of the Quality Objectives.  Monitors all validation & stability activities are completed as per the schedule.  Ensures that all changes impacting the product and the established systems, are documented and reviewed to analyze the impact.  Ensures that all derivations, OOS/OOT & Market complaints are logged, investigated to identify the root cause so as to take CAPA to prevent recurrence.  Preparation of Annual product quality reports, trending of data, determining product and process performance.  To arrange and conduct the self inspection, identify gaps, and take CAPA.  Review of related batch manufacturing records and QC testing data Prior to release of the any batch.
  • 12. QUALITY CONTROL Qc is the part of GMP concerned with the sampling, specifications, and the testing and with the organization, documentation and release procedures which ensures that the necessary and relevant tests are actually carried out and the materials are neither released for use, nor products are used for sale and supply until their quality has been satisfactory.
  • 13.
  • 15.  Preparation of the specifications for testing of the materials and the products.  Carrying out Sampling and testing of materials or the products.  Environment Monitoring.  Conducting stability studies.  Investigating test failures such as OOS/ OOT/ OOAC/ OOAL.  Analytical method validation.  Evaluation of complaint samples. - All the quantity control activities are performed adherence to the GLP.
  • 16. QUALITY METRICS: A tool (ISPE: International Standards for Pharmaceutical Engineers) for continuous improvement in Quality. - It is a measurement standard by which efficiency, performance, progress compliance or quality of a process, or product can be assessed. 1. KPI’S shall be identified based on impact on organization goals and quality. 2. Weightage to be provided for each KPI. 3. Scoring to be provided for each KPI based on actual performance. 4. Communication to top management. 5. Necessary developments to be made to improve the failed KPI. -> e.g. of KPI- Batch failures, Market complaint, deviations, Changes, OOS, Stability Overdue, RM/PM/FG release time.
  • 17. QUALITY ASSURANCE “ Planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for the quality”. -Quality Assurance is a system for evaluating performance, service, of the quality of a product against system, standard or specified requirement for customers.
  • 18.
  • 19. OBJECTIVE OF QA(Quality Assurance)- 1. Managing good manufacturing practices (GMP) including. 2. Managing good laboratory practices (GLP). 3. Managing a safety programme. 4. Assuring the quality of raw materials. 5. Assuring the quality and traceability of finished product. 6. Evaluating plant environment. 7. Developing an HACCP plan.
  • 20.
  • 21. FUNCTIONS OF QUALITY ASSURANCE:- 1. To maintain standards & specification for all the raw materials & finished products. 2. To give service to the company in all areas related to the product quality includes trouble shooting, visiting, production, facilities, designing and training Quality control panel. 3. To produce information that is accurate, reliable and adequate for the intended purpose. 4. Evaluating performance, service, of the quality of a product against a system, standard or specified requirements for costumers.
  • 23. SCOPE OF QA/QC IN PHARMACEUTICAL SR NO. Criteria Quality Assurance Quality Control 1. Focus To prevents defects with a focus on the process. To identify defects in the finished product. 2. Goal To improve development and test processes so that defects do not arise. To identify defects after a product is developed and before it’s released. 3. How Establish a good quality management system & assessment of its adequacy with continuous monitoring. Finding sources of quality problems to continually meet customer’s requirement.
  • 24. SCOPE OF QA/QC in pharmaceutical SR NO. CRITERIA QUALITY ASSURANCE QUALITY CONTROL 4. What Prevention of quality problems through planned and systematic activities. Analytical techniques used to maintain the product quality and process. 5. Responsibility Everyone on the team. Of a specific team that tests the product for defects. 6. As a tool QA is a managerial tool. QC is a corrective tool.
  • 25. GMP(GOOD MANUFACTURING PRACTICES) -> Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of the drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
  • 26. GENERAL REQUIREMENTS:-  Avoid risks and possibilities of mix-up at all stages of Mfg., labelling Pkg and testing.  AHUs, comfort of the personnel working and the regular monitoring of the temperature & humidity, Particle count, DOP testing etc.  Proper drainage system which prevents backflow. Avoid open channels and if provided must be able to clean and disinfect.
  • 27. COMPONENTS OF THE GOOD MANUFACTURING PRACTICES(GMP)
  • 28. TEN PRINCIPLES OF GMP 1. Design and construct the facilitates and equipment's properly. 2. Follow written procedures and Instructions. 3. Document work. 4. Validate work. 5. Monitor facilitates and equipment. 6. Write step by step operating procedures and work on the instructions. 7. Design, develop and demonstrate job competence. 8. Protect against contamination. 9. Control components and product related processes. 10. Conduct planned and periodic audits.
  • 29. GMP GUIDELINES • GMP as per Schedule ‘M’. • GMP as per WHO. • GMP as per MCA now known as MHRA. • GMP as per TGA. • GMP as per US FDA. • GMP as per ICH guidelines. - WHO:- World Health Organization. - MHRA:- Ministry of Health and Regulatory Affairs. - TGA:- Therapeutic Good Affairs. - FDA:- Food and Drug Administration. - ICH:- International Conference on Harmonization.
  • 30. Why GMP is important? • Avoids poor quality medicines, a health hazards. • Saves waste of money for both Government and individuals consumers. • Helps boost pharmaceutical export opportunities. • Reduces and prevent errors. • Prevents contamination & cross contamination. • Minimize variance in drug potency. • Prevents toxicity. • Prevents mislabeling. • Avoids adulteration.
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  • 32. SOME OF THE MAJOR RISKS ARE:-  Unexpected contamination of products, causing damage to the health or even the death.  Incorrect labels on containers, which could mean that the patients receive the wrong medicine.  Insufficient or too much active ingredient, resulting ineffective treatments or adverse effects.
  • 33. CONCLUSIONS: From the above discussion we can conduct that- 1. Pharmaceutical industry is regulated by the GMPs. 2. Good Manufacturing Practices must be followed. 3. GMPs ensure drugs products are safe, pure and effective.