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For convenience, we compiled some useful links, that we hope you find handy!
GMP Guidelines
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UPDATED JULY 1st 2020 - HEALTH CANADA: GUI-0001 Good Manufacturing Practices Guide for Drug Products (GUI-0001)
HEALTH CANADA: Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API) - (GUI-0104)
UPDATED August 25th, 2020: HEALTH CANADA: Annex 7 (GUI0066) to the Good manufacturing practices guide for drug products - Selected non-prescription drugs
UPDATED August 24th, 2020: HEALTH CANADA: GUI-0069 Guidelines for environmental control of drugs during storage and transportation
UPDATED August 31st, 2020 HEALTH CANADA: Risk classification guide for drug good manufacturing practices observations (GUI-0023) – Summary
EUROPE: EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines
FDA: PART 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General
FDA: PART 211 - Current Good Manufacturing Practices for Finished Pharmaceuticals
HEALTH CANADA: Cleaning Validation Guidelines (GUI-0028)
HEALTH CANADA: Guidance - How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
ISSUED September 15th, 2020, Implementation Date, March 15th 2021 HEALTH CANADA Summary of Annex 3B to the Good manufacturing practices guide – Positron-emitting radiopharmaceuticals
UPDATED July 17th 2020 HEALTH CANADA (GUI -0005) Explanatory notes for drug establishments on the preparation of a site master file
Health Canada GUI-0039 Drug and natural health products recall guide
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