Annex 2 to the Good manufacturing practices guide - Manufacture of biologics (GUI-0027): References
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Canadian references
Canadian acts
- Food and Drugs Act
- Health of Animals Act
- Transportation of Dangerous Goods Act
- Safe Food for Canadians Act
- Human Pathogens and Toxins Act
Canadian regulations
- Food and Drug Regulations
- Health of Animals Regulations
- Transportation of Dangerous Goods Regulations
- Safe Food for Canadians Regulations
- Human Pathogens and Toxins Regulations
- Blood Regulations
- Safety of Human Cells, Tissues and Organs for Transplantation Regulations
Other Canadian references
- Good manufacturing practices guide for drug products (GUI-0001)
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
- Guidance document – Annex 13 to the current edition of the Good manufacturing Practices guidelines drugs used in clinical trials (GUI–0036)
- Guidance on drug establishment licences (GUI-0002)
- Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
- Guidance document: Preparation of clinical trial applications for use of cell therapy products in humans
- Cleaning validation guide (GUIDE-0028)
- Guidelines for environmental control of drugs during storage and transportation (GUI-0069)
- Guide to validation of terminal sterilization process of drugs (GUI-0074)
- Guide to validation – drugs and supporting activities (GUI-0029)
- Guidance document: Plant molecular farming (PMF) applications: Plant-derived biologic drugs for human use
- Bovine spongiform encephalopathy import policy for bovine animals and their products and by-products
- Regulatory requirements to minimize the risk of transmission of transmissible spongiform encephalopathies (TSEs) via animal-sourced materials used in the manufacture of Schedule D (biologic) drugs
- available upon request by sending an email to bgtd.opic-bpci.dpbtg.sc@ hc-sc.gc.ca
- Canadian biosafety standards and guidelines
- Canadian Biosafety Standard (CBS), third edition
- Canadian Biosafety Handbook, second edition
- Codes of practice for the care and handling of farm animals
- CSA Z902: Blood and blood components, Standards Council of Canada
International references
PIC/S references
- Guide to good manufacturing practice for medicinal products Part I
- Guide to good manufacturing practice for medicinal products Part II
- Guide to good manufacturing practice for medicinal products annexes (PIC/S)
- PIC/S Annex 2A: Manufacture of advanced therapy medicinal products for human use
- PIC/S Annex 2 B: Manufacture of biological medicinal substances and products for human use.
- PIC/S Annex 14: Manufacture of products derived from human blood or plasma
- PIC/S Good practice guidelines for blood establishments and hospital blood banks
European Medicines Agency (EMA) references
ICH references
- Guidance documents developed by the International Conference on Harmonisation (ICH) and adopted by Health Canada
- available in the drug products section under ICH (International Conference on Harmonisation)
- ICH Q5A R1: Guideline: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- ICH Q5A R2: Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
- ICH Q5B: Quality of biotechnology products: Analysis of the expression construct in cells used for production of R-DNA derived proteins
- ICH Topic Q5C: Quality of biotechnological products: Stability testing of biotechnological/biological products
- ICH Q5D: Derivation and characterization of cell substrates used for production of biotechnology/biological products
- ICH Q9 R1: Quality risk management
- ICH: Q6B Guideline: Specifications: Test procedures and acceptance criteria for biotechnological/biological products
- ICH: Q11 Guideline: Development and manufacture of drug substances (chemical entities and biotechnological/biological entities)
US Pharmacopeia
- USP <92> Growth factors and cytokines used in cell therapy manufacturing
- USP <1043> Ancillary materials for cell, gene and tissue-engineered products
- USP <1046> Cellular and tissue-based products
- USP <1047> Gene therapy products
WHO references
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