INDUSTRIAL PROCESS VALIDATION: A REVIEW

Authors

  • Vipin Kumar Department of Pharmaceutics, Rayat Institute of Pharmacy, Rail Majra S.B.S Nagar, Punjab, India

Keywords:

Validation, Process Qualification, process design, validation master plan.

Abstract

Validation is defined in the supplementary information section of the Federal Register as “a QA function that helps ensure drug product quality by providing documented evidence that the manufacturing process consistently does what it purports to do [1]. Process validation provides a higher degree of assurance that the manufacturing process consistently meets the pre-determined specifications and the quality products output can be used to increase purity. . It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practice and other regulatory requirements.

 

KEY WORDS: Validation, Process Qualification, process design, validation master plan.

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Published

2013-06-30

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Section

Articles