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Executive CommitteeDr. S. G. PATEL Secretory, CVMOne day National Seminar On Quality by Design Approach in Tablet FormulationsDr. NIKHIL ZAVERI Director General, CVMREGISTRATION FORMChief PatronGUJCOST

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How to fill out quality by design approach

01

Understand the critical quality attributes (CQAs) of the product

02

Identify the critical process parameters (CPPs) that can affect the CQAs

03

Design experiments to explore the relationship between the CPPs and CQAs

04

Use statistical tools to analyze the data and identify the best process parameters

05

Develop a control strategy based on the identified CPPs and CQAs

Who needs quality by design approach?

01

Pharmaceutical companies

02

Biotechnology companies

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Medical device manufacturers

04

Any industry that requires consistent high-quality products

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What is quality by design approach?

Quality by design approach is a systematic method for development that begins with predefined objectives and emphasizes product and process understanding and control.

Who is required to file quality by design approach?

Pharmaceutical companies and manufacturers are required to file quality by design approach.

How to fill out quality by design approach?

Quality by design approach is filled out by providing detailed information about the product and process understanding, control strategies, and risk assessment.

What is the purpose of quality by design approach?

The purpose of quality by design approach is to ensure consistent product quality and to reduce the risk of product failure during manufacturing processes.

What information must be reported on quality by design approach?

Information about product and process understanding, control strategies, risk assessment, and validation protocols must be reported on quality by design approach.

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