FDA Guidance for Industry: Q2(R2) Validation of Analytical Procedures

Title:
FDA Guidance for Industry: Q2(R2) Validation of Analytical Procedures

https://www.gmp-compliance.org/files/guidemgr/48994720dft_ich-q2r2.pdf

Origin/Publisher:

FDA

Content:
This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological / biotechnological).

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