Health Canada releases step-by-step guidance on developing an effective Corrective and Preventive Action Plan (CAPA), consisting of three types of actions: Immediate, Corrective, and Preventive Action. All regulated parties (manufacturers, importers, packagers, and labelers) must build comprehensive CAPAs to address any good manufacturing practices (GMP) deficiencies or non-conformities with natural health products.
CAPA Process
Health Canada’s Role
Health Canada is responsible to do site inspection to ensure all sites conducting licensable activities are complying with the Natural Health Products Regulations. An inspection exit notice will be issued including the inspection rating and observation identified during the inspection. HC will issue a notice and cover letter indicating the date for the company to provide a written CAPA plan to address any issues during the site inspections.
Stakeholders are reminded to document the CAPA plan including the evidence which could be in any form (photo, bills, or updated SOP) as the investigator or HC may request for evidence during the inspection. Any extension of the confirmed completion date should also be accompanied by thorough explanations and an updated action plan.
Source: Health Canada
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