Pharmaceutical industry, and more particularly pharmacovigilance, is strictly controlled field in terms of having many regulations and laws established by health authorities with rigid timelines to follow.
To ensure that requirements for monitoring the safety of medicines are met, it is mandatory for MAHs’ PV systems to be audited by internal and external auditors and also by inspectors from national competent authorities.
Let’s face the truth, MAH who had no inspection, sooner than later will have to meet this challenge, whereas those already controlled, should be prepared for re-inspections.
Inspections conducted by various competent authorities may differ in the way they are carried out, but one thing is certain - if a PV system works properly, we have nothing to be afraid of. However, if there are deficiencies, the inspectors, who are experts in this field, will easily identify them and the findings may result in serious ramifications for the MAH.
Types of PV inspection
The course of the inspection process may depend on many factors, the inspection itself may be announced - commonly planned as part of an inspection schedule, referred to as ‘routine’ inspections or unannounced - usually "for cause" inspections which investigate issues when a certain trigger is recognized. An inspection may concern a selected part of the PV system or the entire PV system. It’s worth to remember, that even pre-authorisation inspections (for Marketing Authorisation Applicant) may be requested in specific circumstances.
Moreover, during unusual situations, such as COVID-19 pandemic, many Competent Authorities are able to conduct remote pharmacovigilance inspections of MAHs, instead of those on-site.
What to expect during PV inspection?
Depending on the scope, PV system and portfolio complexity, the inspection may last from one to several days. In the course of the inspection, inspectors are entitled to control the marketing authorization holders’ pharmacovigilance system, verify data bases and MAH’s documentation regarding pharmacovigilance and request clarifications concerning the functioning of the pharmacovigilance system. Also, relevant qualified personnel, involved in PV activities, must be ready for interviews, including the QPPV. It’s worth to remember that it’s not enough to have a good PV system in place. During the interview employees must be ready to clearly answer insightful questions from inspectors and to get through it efficiently they need to be well prepared and have appropriate experience and skills, also the linguistic ones.
Findings and penalties
Even if MAH delegates its PV activities to other service providers, all responsibilities regarding PV still lie on MAH, thus this is crucial to have an overview on all activities performed.
To understand how broad is the scope of the duties, let's take a look at the most common inspection finding, listed below:
- Adverse reactions - reports not processed and submitted on time; under-reporting or erroneous reporting; poor quality of adverse reaction reports evaluation; lack of follow-up on adverse reaction reports or follow-up conducted too late.
- Quality management systems - outdated, incomplete or lacking standard operation procedures; deviations not handled according to deviation system.
- PSMF – documents do not reflect the actual PV system; annexes to PSMF are incomplete or outdated.
- Organization and staff - QPPV not adequately qualified or with insufficient overview or without access to medically trained staff; inadequately trained personnel to ensure compliance.
- Literature searching - not conducted in accordance with legislative requirements; inadequate local literature reviews.
- Periodic safety update reports - not submitted on time or content not in accordance with regulations.
- Reference documentation – safety variations not submitted within the acceptable deadlines; no procedures regarding submission of variations.
- Cooperation agreements - missing documents; contracts without information on exchange of data about adverse reactions and specific timeframes or timeframes not ensuring timely reporting; lack of reconciliation of information.
- Audits - contact partners not audited within the context of PV.
- Electronic databases - no tracing changes for critical processes; systems not validated; inaccuracies between source data and data entered in the database, deficiencies in quality control of data entered or in access control.
When non-compliance with PV responsibilities is detected, the necessary action will be judged on a case-by-case basis by controlling authority. What action is taken will depend on the potential negative public health impact of the findings. Potential regulatory actions include: provision of information on findings to other competent authorities, re-inspection, warning letter, infringement notice, placing on the list of MAHs found to be extremely or persistently non-compliant; suspension or revocation of the marketing authorization, product recall, financial penalties or even referral for criminal prosecution with the possibility of imprisonment.
Is it possible then to sleep well, knowing how many responsibilities lie on MAH’s shoulders and how serious may be the consequences of not fulfilling them?
How can we help you?
At SciencePharma, we have an experienced and perfectly trained pharmacovigilance team, ready to help your company in preparation and during the course of pharmacovigilance inspection itself. So get in touch today to see how we can help you to meet your legal requirements, with respect to pharmacovigilance. With SciencePharma it’s possible to always be inspection ready and… sleep calmly.