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

ISBN-13: 9780982147658 / Angielski / Miękka / 2010 / 650 str.

Mindy J. Allport-Settle

Opis

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