Drug Establishment Licences & COVID-19

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Good manufacturing practices (GMP) is the quality standard that must be met by companies manufacturing, importing and distributing drugs in Canada. In order to ensure compliance with GMP, Health Canada has a unique and targeted license process for applicants which involves an initial on-site inspection, vetting of foreign supply sites and renewal and reinspection according to pre-set frequencies.

In order to assist with compliance measures including enforcement Health Canada has created a special division, the Regulatory Operations and Regions Branch for managing ongoing compliance of licensed parties with respect to health products regulated by The Food & Drugs Act. The RORB oversees compliance of Drug Establishment License (DEL) holders in a risk-based step wise fashion as per Policy 0001 – Compliance and Enforcement Policy for Health Products.

Health Canada’s latest DEL Bulletin (#84) “Guidance on Business Impact Mitigation and Additional Measures for Operational Relief amid COVID-19” provides some guidance to industry on Health Canada’s expectations during the pandemic. Based on the current situation, operational adjustments may need to be made by licensed parties and their supply chain partners. Health Canada reminds industry to address any proposed changes with careful attention to how those changes impact Good Manufacturing Practices (GMP) compliance. Proposed changes should be evaluated in accordance with Quality Risk Management (QRM) principles that consider the best interests of patients and quality of drug products. Industry is encouraged to consult the International Council for Harmonisation Q9 Quality Risk Management guide recommended for assistance with implementation of operational changes.

Examples of changes that could be considered and evaluated under QRM principles include:

  • adjustments to equipment calibration or equipment maintenance frequencies
  • revised approaches to vendor audits (such as deferral of on-site audits or use of desk-top audits)
  • deferral of periodic confirmatory testing for raw materials or imported drugs
  • deferral of ongoing periodic training

Interim measures adopted by DEL holders should be properly documented. Record keeping and change control are important aspects GMP compliance. These processes may need additional attention to cover temporary adjustments that impact GMP compliance for Canadian and foreign facilities.

DEL Bulletin #84 reminds DEL holders to consider market authorizations for all products to ensure that changes to pharmaceutical quality systems do not result in distribution of non-compliant drug products. Unless informed otherwise by Health Canada through interim orders, the requirements expressed in the Food and Drugs Act, and The Food and Drug Regulations remain in effect.