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/51919313fnl-q2-r2-validation-analytical-procedures.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).