Quality should be build in to the product, and testing alone can not be relied on to ensure quality of products

1. Quality Management System

2. “Quality should be build in to the product,
and
testing alone can not be relied on to
ensure
quality of products.”

3. Objectives of Quality Management
• Provide high quality drug products to patients
and prescribers.
• Prevents and reduce number of recalls,
returned or salvaged products, and defective
products entering the market place.
• Harmonise the cGMPs. To the extent possible
with other widely used quality management
systems like ISO-9000.

4. Objectives of Quality Management
• To handle many types of changes to facilitate,
equipments and processes without the need for
a regulatory submission.
• To help in getting Quality by design.
• To achieve success in business, in modern
performance oriented markets, by improving
the enterprises competitive position, increasing
productivity, improving risk management and
thus increase profitability.

5. Quality Management System
• Modern quality management system involves
following concepts:
1. Quality
2. Quality by design and product development.
3. Risk management and Risk Assessment
4. Corrective and Preventive Action (CAPA)
5. The Quality Unit

6. Quality Management System
1. Quality
 Every Pharmaceutical Product must meet the
following four attributes namely identity, strength,
safety and purity to achieve the desired
effectiveness of the product.

7. 2. Quality by design and product development
• Means designing and developing the pharmaceutical
products during product development stage to
achieve the desired characterization in the product.
Quality Management System

8. 3. Risk management and risk Assessment
• Risk management guides us in establishing
specifications and process parameters.
• Risk assessment is used in determining need for
investigation and taking necessary action.
Quality Management System

9.  It is well known cGMP
concept
 It focuses on investigating
and correcting
discrepancies and
attempting to prevent its
recurrence.
 Remedial corrections
 Root cause analysis
 Preventive actions to prevent
initial occurences.
Quality Management System
4. Corrective and Preventive action (CAPA)

10.  Modern pharmaceutical
industry practice is to
divide the responsibility
of Quality Unit in to two
parts namely
1. Quality Control
2. Quality Assurance
Quality Management System
5. The Quality Unit

11. INTER-RELATION BETWEEN GMP & QA
& QC