Notice to Stakeholders - Release of Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104) for Consultation

From: Health Canada

Current status: Open

Opened on December 31, 2018 and will close to new input on March 31, 2019.

This revised guidance document contains new information. Plain language principles to make the document easier to read and understand have been considered in rewriting and formatting the document. It will continue to support compliance with Good Manufacturing Practices (GMP) and Drug Establishment Licence requirements prescribed in Part C, Division 1A and Division 2 of the Food and Drug Regulations (FDR). The key changes to the document are listed below.

Join in: how to participate

1. Review guidance documents

The consultation document can be obtained by writing to hc.api.questions-ipa.sc@canada.ca.

2. Submit comments

You may email your comments to hc.api.questions-ipa.sc@canada.ca or mail them to the address, below. All comments will be considered in finalization and adoption of the document. The consultation period runs from December 31, 2018 to March 31, 2019.

Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa Ontario K1A 0K9

Who is the focus of this consultation

We will engage with:

  • Drug Establishment License holders
  • Pharmaceutical industry
  • All other interested parties

Overview of Key Changes

The Health Canada guidance document has been rewritten and formatted using plain language principles to make the document easier to read and understand. This is in conformance with requirements for migration of documents to the Canada.ca website.

Other changes include:

  • An expanded scope to include veterinary active pharmaceutical ingredients (API) and importation for the purpose of compounding
  • Added information to clarify that the scope includes cannabis APIs
  • Updated information to align with applicable sections of the current Good Manufacturing Practices guide for drug products (GUI-0001)
  • Added clarity to help you satisfy GMP regulatory requirements depending on the API activities being conducted at the building
  • New information to provide clarity regarding analytical test methods
  • New information regarding re-packaging, testing and sampling requirements
  • New information regarding re-testing of APIs
  • Updated information on stability testing and API intermediates
  • Added definitions related to antimicrobial resistance and antimicrobial agents
  • Added definitions related to cannabis APIs

Related information

Health Canada recognizes there are ongoing discussions regarding the potential implementation of a new Self-Care Framework. However, until regulatory amendments are finalized to support the Self-Care Framework, Health Canada will continue to update guidance documents according to existing requirements under the Food and Drugs Act and Regulations. Upon implementation of the Self-Care Framework, Health Canada will revise guidance documents as appropriate.

Contact us

Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa Ontario K1A 0K9

hc.api.questions-ipa.sc@canada.ca

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