Pharmaceutical Process Validation

Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.
2018-03-07 Pharmaceutical Validation Book or Program 2678 views Editor: Mohamed Atia


The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation [1]:
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process (such as the manufacture of pharmaceutical dosage forms) will consistently produce a product meeting its predetermined specifications and quality characteristics.

Pharmaceutical Process Validation

An internation third edition, revised and expanded

Edited by:
  • Robert A. Nash
  • Alfred H. Watcher

File Size: 4.33 mb

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