Pharmacovigilance (PV) has been the rising regulatory star since the introduction of European Union (EU) legislation in 2012 which continues to be an inspiration for other regulatory authorities worldwide. Many authorities place a significant focus on PV inspections to ensure compliance and to implement enforcement measures, where necessary. This is to ensure that all stakeholders comply with legislation and PV obligations as well as to assist with quality improvements within their systems. As PV inspections increase globally, the expected global compliance standards for industry continues to increase also.

There is no general rule of thumb to determine when a PV inspection may take place, or even be announced. The best approach therefore is to remain inspection ready. This will help minimize the impact of a PV inspection, as well as reduce the possible number of findings following the inspection.

A common issue from our first-hand experience of conducting mock PV inspections is that companies are not fully aware of regulatory authority expectations and how to manage the inspection process. The best way to mitigate against this is to experience a realistic mock inspection.

How do you ensure your company is inspection ready? The answer is simple – prepare!

ADAMAS has three former PV inspectors from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the Turkish Medicines and Medical Devices Agency who can support you. Combining mock inspections alongside your PV audit program can improve your PV systems, allow you to experience what it is like to undergo an inspection and maintain preparedness for a real PV inspection.

PV inspections are designed to review the entire PV system, however the scope may vary based on the inspection type and size of the PV system. Inspections may be performed either completely on site, completely remotely or have an element of both. In all circumstances, it is key to have the appropriate personnel prepared and ready to give precise and concise responses to questions. Ambiguity is not an option! Timely verbal and written responses to requests are crucially important and large volumes of documents are often requested. If you are not prepared, the logistics can be challenging and can also lead to unexpected findings.

The following five considerations may assist you to prepare:

  • A robust Quality Management System (QMS) as a foundation for the PV system is essential. Critical PV processes should be determined and business continuity ensured. At the core of the QMS robust procedures should be in place that define how PV activities are conducted. Compliance with these procedures is key to a functioning and compliant PV system.
  • Robust good documentation practices for PV activities are essential, which will in turn allow your company to trace and demonstrate the activities conducted. This involves validation of electronic tools used for the conduct of PV activities.
  • The core of the PV system are your people. Your company personnel need to be adequately trained from the time of onboarding and throughout their employment. Training records should be created and maintained in reliable repositories where they can be readily accessed for audit or inspection purposes.
  • Robust quality assurance processes allow for a healthy quality system through the continuous monitoring, identification and correction of compliance issues. Quality assurance processes should include the conduct of systematic, unbiased and risk-based PV audits, as well as a system to detect and correct deficiencies identified by other oversight mechanisms. Your company should have in place adequate and documented quality checks to ensure those activities that include any form of manual processing undergo a thorough and independent review by competent personnel.
  • Finally, your company needs to have a process to maintain one of the essential documents within the EU, the PV System Master File (PSMF). The PSMF will be the basis for any PV inspection conducted within the EU PV regulatory network. The PSMF should be kept up to date and include accurate and current information on the PV system. There should be mechanisms to update the PSMF regularly to ensure that your company is ready for inspections at any time.

A final thought from us as former inspectors, we all share the same goal of protecting public health. Open collaboration with the inspectors is therefore essential. This collaboration should remain throughout the entire process, from preparation through to inspection conduct and reporting.

It is crucial to establish and maintain these good practices at the core of your PV system, not only from the perspective of your standard daily ongoing compliance activities, but also to ensure you remain as prepared as possible for PV inspections.

At ADAMAS, we are conscious that in these difficult times our clients have an ongoing need for inspection readiness and current travel restrictions make this challenging, ADAMAS is well placed to assist with conducting mock inspections remotely.

In addition, please check out our dedicated COVID-19 series webpage to learn even more about our remote service offerings.

If you would like to learn how ADAMAS utilise our extensive experience in this area to ensure our remote mock inspections are as successful as possible, please feel free to call us on +44 (0)1344 751 210 in Europe, +1-919-341-3361 in the US; or email us at info@adamasconsulting.com.

The ADAMAS Team.

The ADAMAS Corporate Brochure 2016

 

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

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ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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