GVP Audit Readiness: Your guide to pharmacovigilance audit success

Health Canada GVP inspection is designed to assess compliance of foreign and local MAHs to the GVP guidelines, to ensure an adequate system is in place for monitoring the safe and effective use of medicinal products.¹ As such, compliant rating is critical to the continuity of care and betterment of patients.

Health Canada has clearly established guidelines and requirements that require all marketing authorisation holders (MAH) to perform audits of their pharmacovigilance systems, including risk-based audits of their SOPs and systems. This requirement is not new. Yet it is confounding why many MAHs struggle with associated audits and inspections.

Although predictable in its cycles, HC can audit any organization at any time. Companies with the least observations constantly remain up to date with their PV systems and have a quality and learning mindset. This is what sets them apart from companies that fall short during the audits.

The main purpose of a PV audit by regulating authorities is to be confident that standards are being upheld and that nothing is being missed. The key question is not about passing the scheduled GVP audit. It Is about getting ahead of the game and be audit-ready at all times to ensure efficient and compliant PV system in place.

This requires the MAH to perform continuous and diligent day-to-day work to ensure compliance to GVP guidelines and in doing so, one can be audit ready at all times- not just when an audit is announced.

In our experience, the common areas where MAHs tend to fail in maintaining a compliant PV system include but not limited to the following- despite SOPs that may be in place ^2,3:

• Failure to demonstrate adequate procedures for managing ADR processing and handling
• Lack of proper qualification of work performed by external service partners;
• Insufficient or poorly documented training and training records and PV oversight;
• Lack of multiparty PV agreements that outline the respective PV responsibilities of each party
• Inconsistent or inadequate collection and management of safety information
• Ongoing safety evaluation failings that include benefit-risk and signal management and aggregate reports (ASRs and PSURs)
• Lack of Qualified personnel and adequate resources
• Failure to ensure safe archiving/backups, digital archiving and business continuity planning
• Failure to address past GVP inspection observations and CAPA implementation.

Best in class companies don’t wait for the next audit date to be announced. Audit-readiness assessments is part of their continuous improvement cycle and are completed at times, on an annual basis. With adequate advanced planning, and support from our experts who will plan and execute this for you, you too can look forward to your next audit with confidence and achieve a complaint rating.

References:

1. About good pharmacovigilance practices (GVP) inspections: About good pharmacovigilance practices (GVP) inspections – Canada.ca
2. Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102): Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102) – Canada.ca
3. Zenith PV Guide to a successful audit handbook