An Overview of the Functions of Quality AssuranceQA

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An Overview of the Functions of Quality Assurance(QA) PART-I What is Quality Assurance &

An Overview of the Functions of Quality Assurance(QA) PART-I What is Quality Assurance & what are the Objectives, Components of QA? ? PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES AND TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA

LEARNING OUTCOME After watching this video we are going to LEARN: • What is

LEARNING OUTCOME After watching this video we are going to LEARN: • What is quality? ? • What is Quality Assurance? ? • Objectives of Quality Assurance • Components of Quality Assurance

What is Quality? ?

What is Quality? ?

What is Quality? ? • Definition of Quality: It is the degree to which

What is Quality? ? • Definition of Quality: It is the degree to which a set of inherent characteristics fulfills requirements. Also can be referred as the ability of one’s product or service to satisfy.

What is Quality Assurance? ?

What is Quality Assurance? ?

What is Quality Assurance? ? • Planned and systematic activities implemented within the quality

What is 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 quality. • QA is a system for evaluating performance, service, of the quality of a product against standard or specified requirements for customers.

Objectives of Quality Assurance

Objectives of Quality Assurance

Objectives of QA • Managing Good manufacturing practice(GMP) • Managing Good laboratory practices(GLP) •

Objectives of QA • Managing Good manufacturing practice(GMP) • Managing Good laboratory practices(GLP) • Managing a safety programme • Assuring the quality of raw materials • Assuring the quality and traceability of finished product • Evaluating plant environment • Developing an HACCP plan.

Now please take a pause for 2 minutes to recapitulate the topics we have

Now please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • What is Quality? ? • Define Quality Assurance • What are the different Assurance? ? objectives of Quality

Components of Quality Assurance

Components of Quality Assurance

Components of Quality Assurance • Long-term decision: - Quality policy • Medium-term decision: -

Components of Quality Assurance • Long-term decision: - Quality policy • Medium-term decision: - Training, facilities, operation of QA. • Day to day operation: - SOP’S

In the Next Video we are going to learn about: - • General principles

In the Next Video we are going to learn about: - • General principles of Quality Assurance • Functions of Quality Assurance • Activities in Quality Assurance

Prepared by: Mr. Ankit Chowdhury Ms. Anjana Sinha Ms. Minakshi Hore Dr. Kishanta K.

Prepared by: Mr. Ankit Chowdhury Ms. Anjana Sinha Ms. Minakshi Hore Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA