Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference

ISBN-13: 9780982147641 / Angielski / Miękka / 2010 / 828 str.

Mindy J. Allport-Settle

Opis

Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing Practices Part II: Guidance Documents Part III: Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines Part IV: Questions and Answers Part V: International Conference on Harmonisation (ICH) Guidance Documents - ICH Q1A(R2): Stability Testing of New Drug Substances and Products - ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products - ICH Q1C: Stability Testing for New Dosage Forms - ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology - ICH Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - ICH Q9: Quality Risk Management, Part VI: Compliance Policies Part VII: Forms Part VIII: Extensive Index