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Regulatory Update: new GMP and DEL Guidance Documents

By: Teri Jenner, Manager Regulatory Affairs Group, email

Health Canada recently announced the release of 5 draft guidance documents for a 90-day consultation period ending April 18, 2017.

  • 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

For a complete overview of the changes in each of the documents please see the following Notice to Stakeholders.


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