International Conference on Harmonisation (ICH) Quality Guidelines
Download or Read eBook International Conference on Harmonisation (ICH) Quality Guidelines PDF written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2010-05 with total page 650 pages. Available in PDF, EPUB and Kindle.
| Author | : Mindy J. Allport-Settle |
| Publisher | : Pharmalogika |
| Total Pages | : 650 |
| Release | : 2010-05 |
| ISBN-10 | : 0982147651 |
| ISBN-13 | : 9780982147658 |
| Rating | : 4/5 (51 Downloads) |
Book Synopsis International Conference on Harmonisation (ICH) Quality Guidelines by : Mindy J. Allport-Settle
Book excerpt: 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
