Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119): References

• Food and Drugs Act
• Food and Drug Regulations
• Good manufacturing practices guide for drug products (GUI-0001)
• Process validation: Aseptic processes for pharmaceuticals (GUI-0006)
• Guidance on drug establishment licences (GUI-0002)
• Good manufacturing practices for active pharmaceutical ingredients (GUI-0104)
• Guide to validation – Drugs and supporting activities (GUI-0029)
• Annex 17, Parametric Release (PIC/S) - Guide to good manufacturing practice for medicinal products annexes
• Process validation: Gaseous sterilization for pharmaceuticals (GUI-0007)
• Process validation: Irradiation sterilization for pharmaceuticals (GUI-0009)
• Process validation: Moist heat sterilization for pharmaceuticals (GUI-0010)
• ISO standards
  • ISO 14644-1: Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration
  • ISO 14644-2: Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
  • ISO14644-3: Cleanrooms and associated controlled environments – Part 3: Test methods
  • ISO 14644-4: Cleanrooms and associated controlled environments – Part 4: Design, construction and start-up
  • ISO 14644-5: Cleanrooms and associated controlled environments – Part 5: Operations
• PIC/S Annex 12 - Use of ionising radiation in the manufacture of medicinal products
• PIC/S Annex 15 – Qualification and validation
• PIC/S GMP guide annexes

Note: The ISO standards referenced in this document were applicable at the time of drafting. Future revisions of these standards do not automatically apply to this document. Relevant updates will be reflected in a future version.