Health Canada has announced releases draft guidance documents GUI-0001, GUI-0023, GUI-0031, GUI-0080 and GUI-0119

23-01-17

On January 18, 2017, Health Canada released the following draft guidance documents for consultation relating to good manufacturing practices and drug establishment licensing:

  • GUI-0001: Good manufacturing practices guide for drug products
  • GUI-0023: Risk classification guide for drug good manufacturing practices observations
  • GUI-0031: Good manufacturing practices for medical gases
  • GUI-0080: How to demonstrate foreign building compliance with drug good manufacturing practices
  • GUI-0119: Annex 1 to the good manufacturing practices guide – manufacture of sterile drugs

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