International Conference on Harmonisation (ICH) Quality Guidelines: Pharmaceutical, Biologics, and Medical Device Guidance Documents Concise Reference

Synopsis

ich Quality Guidelines: * Overview And Orientation * Introduction * Part I: Stability [q1a(r2), Q1b, Q1c, Q1d, Q1e] * Part Ii: Analytical Validation [q2(r1)] * Part Iii: Impurities [q3a(r2), Q3b(r2), Q3c(r4)] * Part Iv: Pharmacopoeias (list Overview) * Part V: Quality Of Biotechnological Products [q5a(r1), Q5b, Q5c, Q5d, Q5e] * Part Vi: Specifications [q6a, Q6b] * Part Vii: Good Manufacturing Practice [q7] * Part Viii: Pharmaceutical Development [q8(r2)] * Part Ix: Quality Risk Management [q9] * Part X: Pharmaceutical Quality System [q10] Reference Tools * Part Xi: Questions And Answers For Q8/9/10 Quality Guidance Documents * Part Xii: Combined Glossary And Index For All Quality Guidance Documents