In the last few years, after having audited numerous service providers/ business or licensing partners/ distributors etc., I realized having developed fascination towards this off-shoot of Pharmacovigilance, that is #PhVQA.

Thanks to the GVP modules as well as PSMF pre-requisites, coupled with the requirements for MAH to maintain a 2-5 yearly audit schedule, making it mandatory for MAH’s to conduct internal as well as external PhV audits. Inclusion of open CAPA from major/critical observations in the main body of PSMF may be challenging. After the closure of CAPA, if we exclude from the main body of PSMF, we may still need to include in the PSMF log book.

In the past, companies managed by outsourcing audits to external service providers. However, with an increasing number of audits, it may not be financially viable. Hence companies have started developing in-house PhVQA capabilities. GMP QA auditors, as well as other QA auditors in organizations, find it difficult to get into PhVQA; only a handful manage to succeed. However, it is more likely that personnel with vast PhV domain experience may consider this as a career option. The scope has widened due to the concept of ‘inspection readiness at all times’, integration during M&A as well as database upgrade and data migration.

But yes, one needs to remember that PhVQA is not only about audits. It may include other activities such as change controls, deviations, data integrity, inspection remediation / CAPA, CAPA effectiveness etc. In some organizations, the PhVQA personnel also need to face the inspection.

Biggest Challenge

The biggest challenge in PhVQA function is with regards to ‘reporting’. Ideally, this function should report to the Quality Assurance / Quality Compliance. Still, at times, the Pharmacovigilance heads do not agree with this and want the PhVQA function to report to them. One needs to understand the potential bias in doing so. I recollect having attended an interview in a large pharma company (in 2014), for the PhVQA lead position, and the PhV Head wanted the function to report to him/ her. I ended up debating that the function should report to QA/ compliance. Not surprisingly, the outcome of the interview was not in my favour. But I have no regrets for that.

Conducting / Scheduling PhV Audits

Needless to say, one needs to follow a ‘risk-based approach’ for conducting audits. If not, the MAH may end up spending more time on this activity. The best way to start with is by preparing a PhV risk assessment questionnaire. One can refer to the MHRA risk-based assessment questionnaire for customizing as per their needs, as well as functions. E.g., questionnaire for distributor/partner in the EU may be different from the non-EU distributor.

Nobody would deny that the qualification of a vendor/partner/distributor should be through an external audit. However, one needs to audit the partners based on a risk-based assessment periodically. Periodically still would mean <3 years.

Scheduling the audit may be the next big challenge, considering the availability of required stakeholders.

No audit is complete without an audit agenda. This needs to be shared well in advance and applies to external as well as internal audits. Following-up for CAPA associated with audit observations may be challenging at times and may require escalations too.

The remote audit is a relatively unexplored option, and regulatory authorities welcome this idea in genuine cases, especially if it not safe for the auditors.

Although one would believe that regulatory inspectors are generally not interested in the audit findings, one cannot always assure this.

Pharmacovigilance is a function that may not be accepted positively by many other departments (e.g. sales & marketing) or even the management (? expense function). Despite all these factors, this field still provides a wonderful career opportunity, as Pharmacovigilance Inspections are unavoidable at the end of the day, and no company would like to go wrong!