FDA Releases Long-Awaited Process Validation Guidance

The FDA has issued its long-awaited final guidance on process validation, confirming several recommendations that raised industry concerns with the draft version.

For example, it recommends drugmakers continue monitoring and sampling process parameters and quality attributes at the same level established during process qualification until there is enough data to make significant variability estimates.

The guidance, “Process Validation: General Principles and Practices,” divides process validation into three stages: process design, process qualification and continued process verification. The final version also urges companies to use objective measures, such as statistical metrics, to assure they understand their commercial processes.
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