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FDA Title 21 Parts:
503 B Compounding and Packaging Master Guide Handbook:
- Chapter 3 - Premise and Equipment
GCP Handbook - 21 CFR Parts 11
ICH Q2(R2) and ICH Q14 Analytical Validation 58 FDA Title 21 Parts:Validation 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
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