ICH Q2(R2) and ICH Q14 Analytical Validation 58 21CFR11-606-1271-C-251229

21CFR11-606-1271-C-251229

- Chapter 3 - Premise and Equipment

ICH Guideline on GMP for Active Pharmaceutical Ingredients (ICH Q7)

GCP Handbook - 21 CFR Parts 11

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ICH Q2(R2) and ICH Q14 Analytical Validation 58 21CFR11-606-1271-C-251229Validation of Analytical Procedures Q2(R2) Analytical Procedure Development Q14 ICH Q2R2 and ICH Q14 Objectives: This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical Procedure Development. ICH Q2(R2) provides guidance on selection and