The GVP inspection program in Canada is designed to ensure drug establishments are compliant to the post-approval regulatory requirements outlined in the Good Pharmacovigilance practice (GVP) guidelines [GUI-0102]. Market authorization holders (MAHs) in Canada are inspected based on risk evaluation approach which sets the frequency at which MAHs are inspected by Health Canada.
Regular GVP inspections mainly focus on handling and processing adverse drug reactions (ADRs), as well as preparation of annual summary reports (ASRs) after a drug has been approved. It is conducted either on-site, remote or in a hybrid setting, and aims at thoroughly reviewing all documentation related to the PV system in place of the audited MAH.
Health Canada recently introduced a pilot project for GVP auditing for low risk MAHs. Our guest author, Randy Levitt, PhD – Director, Pharmacovigilance and Medical Affairs at Paladin Labs Inc. provides further insights to the audit pilot project and consideration related to regular GVP audits.
Here is a summary of our discussion with Randy
What is this Audit Pilot Project and why is it important?
In June 2022, Health Canada announced a Pilot project to assess the GVP compliance of lower risk MAHs. Similar to what the MHRA has been doing for years in the UK, this project will allow the Inspectorate to focus their resources on high risk MAHs as they would utilize a risk-based approach to scheduling inspections which would take into account multiple factors such as the MAH’s product portfolio and compliance history.
How does HC identify who is a low-risk MAH and how do they target them?
Health Canada has defined “low risk MAHs” as those foreign and local MAHs who own drugs that don’t represent a safety risk for the population and are not likely to generate many serious adverse drug reactions. This also include MAHs with no indicator of poor compliance with GVP.
What drugs are covered in the scope of the audit-pilot?
- Pharmaceuticals (Over-the-counter and prescription)
- Biologics including biotechnology products, vaccines and fractionated blood
- Medical gases
How is it different from a Periodic GVP audit?
Health Canada informed selected MAHs in July 2022 of their inclusion in the pilot project. Selected MAHs were asked to respond to a questionnaire and provide requested documents by the end of August 2022, which will be reviewed by GVP inspectors. The questionnaire will be used to assess that the MAH has adequate procedures and systems in place, to comply with the Canadian GVP requirements and will serve to evaluate the MAH’s understanding of the requirements. If a MAH’s response is deemed unsatisfactory, an inspection will be scheduled between September 2022 and March 2023.
In addition, Health Canada may decide to inspect a certain number of MAHs who provided a satisfactory response, to verify the accuracy of responses provided. All MAHs asked to respond to questionnaire will be informed of the results of the review by the inspectors.
What are the main areas should MAHs focus on should they be selected for a periodic GVP audit following response to the pilot audit project?
MAHs must demonstrate adequate procedures and systems in place, to comply with the Canadian GVP requirements. In preparation for a GVP audit MAHs must consider the following areas:
- PV Standard operating procedures (PV SOPs) and related SOPs (eg, medical information, product complaints)
- Pharmacovigilance system and database
- Documentation inducing but not limited to training records, deviation investigation, PV agreements, etc
Recently, Health Canada has added the following elements to their standard GVP inspection:
- Risk management plans (as per this guidance document)
- Notifying Health Canada of foreign actions (as per this guidance document)
Will the results of the assessment be posted on-line?
The results of the questionnaire assessment stage will not be made public by Health Canada. The results of regular GVP inspections will however be posted.
About Zenith PV
If you have been notified of an assessment or been selected for an audit, please contact us with any questions regarding this notice. Our experienced team of PV experts will provide the guidance and support you may require complying with the audit as well as Health Canada’s GVP requirements.
Zenith PV can support with the overall audit or specific parts of your audit such as risk management plans after a free gap assessment session with your team.
Call us today to schedule a free one-hour gap assessment call.