Sunday, 1 July 2018

Canada updates its GMPs

On February 28, 2018, the Health Products Compliance Directorate posted four drug good manufacturing practices (GMP) documents to the Health Canada website. These documents are:

Good manufacturing practices guide for drug products (GUI-0001),
Risk classification guide for drug good manufacturing practices observations (GUI-0023),
Good manufacturing practices for medical gases (GUI-0031), and
Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119).

This means new Canadian GMPs are coming. The timeline details are:
  • Published: February 28, 2018
  • Implementation: October 1, 2018
  • Consulted: January 18, 2017 – April 18, 2017
Highlights include:

Content to address issues such as data integrity and new regulations pertaining to active pharmaceutical ingredients (API);
Additional responsibility for importers of products from non-MRA (Mutual Recognition Agreement) countries, including requirements to conduct audits of foreign buildings and increased retesting of imported products;
Removal of guidance related to sterile products and replacement with guidance published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

Posted by Dr. Tim Sandle

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