The Pharmacovigilance Audit of a business partner can be tricky, as there may be direct or indirect commercial implications associated with the audit’s outcome.

A business partner can be a distributor, wholesaler, or even a service provider. For the scope of this article, we will primarily focus on product distributors. There can be more than one business partner in a single country or territory. Regarding product supplies, one can expect business arrangements related to co-marketing, co-distribution, own label /private label supplies or even exclusive distribution or tender.

The marketing /commercial team may be more apprehensive about the audit outcome than the Pharmacovigilance team, as the sales and business relationship may be at stake. The comfort level is higher when the company personnel undertake the audit rather than the vendor or service provider. One cannot afford any bias, as compliance is at stake.

When you come across a new business partner

• What is the scope of activities?
• Does it fall under the Safety Purview?
• What would be the scope of the Safety Data Exchange Agreement (SDEA)?
• What will be the scope of Audit in the future?
• Which of the partners will have the right to audit?

What should you look for during the audit (not limited to)?

Business Partner:

• Awareness and knowledge
• Training and Reconciliation Records
• Written Procedures
• Documentation practices
• Outsourced activities
• Compliance with local regulatory requirements

SDEA:

• Completeness
• Dates
• Product list
• Responsibilities
• Other linked agreements

Caution / Recommendation

• Undertake Risk-Assessment/Scoring for all the business partners
• Questionnaire Assessments are not considered as Audits
• Periodic reconciliation between the Annex B and Annex G of PSMF
• Avoid frequent Risk-based assessment at the cost of not performing an audit. The inspector will anyways identify this!
• Do not postpone an audit very frequently. Remote audits are acceptable!

The best approach may be to undertake vendor assessment or qualify the business partner before onboarding them. Although this will be a norm for Pharmacovigilance service providers, the same is advised for the product distributors. Besides, it is also advisable to have periodic review meetings with these product distributors. This is primarily to ensure that any training requirements (at the distributor’s end) or regulation updates are appropriately handled.