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

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

https://www.gmp-navigator.com/files/guidemgr/51919313fnl-q2-r2-validation-analytical-procedures.pdf

Herkunft/Verlag:

FDA

Inhalt:
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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