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

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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 IndexCanadian Good Manufacturing Practices

Good Manufacturing Practices for Pharmaceuticals