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

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 Index
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