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Informative Article | Engineering Science | India | Volume 10 Issue 4, April 2021 | Popularity: 5 / 10

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Process Validation in the Pharmaceutical Manufacturing Industry

Rohit Singhal

Abstract: Process validation is a crucial component of the pharmaceutical manufacturing industry, ensuring that a process consistently produces a product meeting its predetermined specifications and quality attributes. This paper provides a comprehensive analysis of process validation, exploring its significance, stages, and elements. Additionally, it delves into the current statistical and regulatory perspectives, post-process qualification, and strategies for continued process verification and stability. The paper also outlines qualification strategies, including the assessment of Active Pharmaceutical Ingredients (APIs) and equipment matrices, and emphasizes the importance of a robust risk assessment strategy in process validation.

Keywords: Process validation, pharmaceutical

Edition: Volume 10 Issue 4, April 2021

Pages: 1420 - 1424

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