Oral Dextromethorphan

GMP Adjustments Amid COVID-19

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The sustainability of supply chains has become a global issue introduced by the COVID-19 pandemic. Drug product supply chains in particular face increased challenges given the need for all sites in the supply chain to maintain controlled, specific environmental conditions for drugs stored and transported in Canada. Health Canada, in recognizing the difficulty faced by supply chains such as reduced operations, supply shortages and staffing reductions, has made several announcements to guide industry on which adjustments a supply chain may introduce while maintaining compliance with Good Manufacturing Practices (GMP). Health Canada’s latest EL Bulletin (#86) provides direction to industry on measures for operational relief when storing and transporting drug products; these include:

  • transportation and storage considerations
  • deferral of low risk investigations
  • document approvals when working remotely

Canadian importers, distributors, and wholesalers must ensure that shipping conditions will not impact the safety, efficacy, or quality of the drugs sold to Canadians. Guidance document GUI-0069,  Guideline for temperature control of drug products during storage and transportation should be reviewed in order to fully understand Health Canada’s expectations for storage sites and carriers involved with drug supply chains in Canada.

Changes required within supply chains may result in Canadian suppliers having to use new shipping modes or routes. These changes should be evaluated in accordance with Quality Risk Management (QRM) principles.  New shipping routes should be evaluated to determine potential risks and anticipated extreme environmental conditions. Product-specific stability data, freeze/thaw data and high temperature studies should be requested and maintained on site. Periodic calibration of instruments may be deferred when there is a minimal risk of failure per a QRM assessment. However devices should be checked periodically to ensure they are working within established temperature and humidity limits.

Holding batches of products with shortage concerns to allow the completion of minor or low risk investigations may not be practical or appropriate during the COVID-19 pandemic. However, it is critical to assess all incidents to determine if there is any impact to product quality. Although investigations of minor incidents may be deferred, negative trends should be reviewed and investigated in a timely manner by quality control together with senior management. 

Stay-at-home orders in numerous regions heave resulted in reduced staff available for document and record approvals. Health Canada understands that this is creating difficulty as not all companies have the appropriate controls in place for electronic signatures as per Good manufacturing practices guide for drug products (GUI-0001). In response to such challenges, Health Canada will accept implementation of electronic records and systems that do not fully meet Good manufacturing practices guide for drug products (GUI-0001) provided that steps are taken to ensure their authenticity.