Expertise
Life Sciences
Good Manufacturing Practices
Good manufacturing practice (GMP) requirements and procedures relating to the production of food, drug and natural health products, and medical devices are critical regulatory and safety factors for the Canadian market. Requirements relating to quality assurance (QA) and quality control (QC) may differ from the standards in the US or Europe. It is crucial that companies that manufacture, package, store or distribute products in Canada are aware of their responsibilities. Our expertise includes:
- Review of commercial agreements to ensure compliance with Canadian requirements and to appropriately allocate responsibility
- Guidance on GMP provisions of the Canadian Food and Drugs Act and regulations, as well as Health Canada and ICH guidelines
- Drafting and negotiation of QA and QC services agreements representing product owners/distributors and contract QA and QC providers
- Advice on licenses, including establishment licenses, for Canadian GMP activities
- Review of product and site master file submissions to Health Canada
- Development of GMP policies, procedures, audit plans and guidelines
