QUALITY ASSURANCE CONCEPT

PHARMACEUTICAL QUALITY ASSURANCE

DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY

BIRLA INSTITUTE OF TECHNOLOGY, MESRA

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LEARNING OUTCOME

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After watching this Video lecture we are going to LEARN:

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• Definition and concept of Quality assurance

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• Why Quality Assurance is required

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• Different responsibilities and functions of QA

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• How to implement QA process

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INTRODUCTION

• What is Quality?

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• According to “American Society for Quality” the term quality is defined as the totality of features or characteristics of a product or service on its ability to satisfy given needs.

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• Quality Assurance (QA)

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• Quality Assurance (QA) is a process of verifying whether a product or service meets the established standards of quality.
• It is a systematic approach to testing and evaluating the quality of a product or service.
• QA is an important part of any product cycle as it helps to identify any potential issues and ensure that the product or service is fit for purpose.

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• Roles of QA
• Quality assurance (QA) roles are responsible for creating and performing tests, identifying errors, and providing feedback to verify that a final product meets a company's quality requirements.

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• Why QA is required?
• Quality Assurance aim to help create quality products. The main function of a QA is to prevent defects, and therefore ensure the quality of the development process and its results.

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• Benefits of QA
• The primary benefit of Quality Assurance is that it helps to ensure that the product or service is of the highest quality and meets the established standards. This helps to improve customer satisfaction and reduce the risk of defects.

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• QA also helps to identify any potential issues early on in the product cycle, which can help to reduce costs and improve efficiency.

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Now, Please take a pause for two minutes to recapitulate the topics we have discussed, and try to answer the following question:

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• What do mean by Quality assurance?

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• Why Quality assurance is required?

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RESPONSIBILITIES OF QA

• The QA department is responsible for ensuring that the quality policies adopted by a company are followed.

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• It helps to identify and prepare the necessary SOPs relative to the control of quality.

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• It must determine that the product meets all the applicable specifications and that it was manufactured according to the internal standards of GMP.

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• QA also holds responsible for quality monitoring or audit function.

• QA functions to assess operations continually and to advise and guide them towards full compliance with all applicable internal and external regulations.

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FUNCTIONS OF QA

• Technology Transfer: Involves receipt and review of documents.

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• Validation: This ensures any process, products or equipment meet the established standard.

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• Documentation: This process controls how records are transmitted and archived.

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• Assurance of Quality of Products: This ensures that the product or service meet the prescribed standard.

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• Quality Management Programs: This function focuses on creating programs to ensure that the products meet the right quality standards going forward.

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HOW TO IMPLEMENT QA PROCESS?

• Identifying your organizational goals.

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• Figuring out what your critical success factors are.

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• Identifying your internal and External Customers.

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• Collecting customer feedback.

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• Implementing improvements on a continuous basis.

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• Picking quality management software that is appropriate for your organization's needs.

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• Measure your results.

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Prepared by:

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SRIJEET DASGUPTA

PHARMACEUTICAL QUALITY ASSURANCE

DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY

BIRLA INSTITUTE OF TECHNOLOGY, MESRA

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