Guidance for Industry: Process Validation — General Principles and Practices

U.S. Food and Drug Administration. (2011). Guidance for Industry: Process Validation — General Principles and Practices: Process Validation — General Principles and Practices.

Type

Report

Intellectual base

Grey literature

Year

2011

Link

no authoritative link yet

Cited from

statistics_experimental_design

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Primes

• Validation
  • The FDA's process validation guidance (FDA, 2011) typifies the regulatory approach across these regimes.

    This sourceCenter for Drug Evaluation and Research. Regulatory framework requiring formal documented validation across pharmaceutical manufacturing, with parallels in FDA design controls, FAA certification, and NASA V&V regimes.

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