how industry can prepare for an MHRA GVP inspection.
In addition to that information, the agency pointed out seven things important to know about GVP inspectors and GVP inspections on the MHRA Blog:
GVP Inspectors may not strictly stick to the agenda and may also change the scope of the inspection when they are on site, if a serious non-compliance issue is suspected.
The inspection team may include observers from the MHRA Vigilance and Risk Management of Medicines (VRMM) and Enforcement Groups or other competent authority inspectorates.
A GVP inspector trainee could complete up to 20 inspections in their first 12 months. GVP inspectors undergo a training and accreditation process on joining the MHRA, during which they must demonstrate the requisite skills and knowledge to perform inspections. The aim is to gain accreditation within 12 to 18 months and involves a recommendation by the mentor and operations manager and assessment of the trainee by an expert or designated senior GVP inspector.
GVP Inspectors will expect any documents listed in the PSMF (Pharmacovigilance System Master File) to be readily available for inspection. This includes procedural documents (such as SOPs, working instructions and guides), as well as outputs from pharmacovigilance activities such as safety review meeting minutes, product safety reviews, audit risk assessments and agreements in place with service providers. An indexed library of these types of documents (or at least an index of links to where the relevant GVP documents are held) can help manage document requests during inspections.
Provision of documents electronically is the inspectors’ preference and should allow multiple inspectors access to documents quickly. If documents are required in hard-copy or other formats, this will be specified with making the request.
In many cases, the EU statutory guidance in the GVP modules is self-explanatory. Where it is useful to provide additional clarification or make MHRA expectations clear, Blog posts and guidance documents published on the MHRA website can be used to provide it. However, the published information does not include additional requirements that the MAH (Marketing Authorization Holder) must comply with. The aim is to advise the MAH on the agency´s current thinking on a specific topic, direct to applicable legislation and provide non-statutory guidance on how existing requirements can be fulfilled. The content of the post-authorization Q&As (in relation to GVP) provided on the EMA website should be followed, unless the MAH can provide good justification for deviating from this advice. (For possible changes due to the Brexit please also read Pharmacovigilance: Be prepared for "Hard Brexit").
Maintaining a compliant pharmacovigilance system (PVS) will lead to a successful GVP inspection. More information can be found in MHRA´s annual metrics. The agency´s objectives on inspection are to get a clear picture of the processes and data that make up the PVS. According to MHRA, a successful GVP inspection is one where the agency has been able to navigate the PVS.