Good Pharmacovigilance Practice: The inspection process

The inspection process
An outline of the inspection process is available below:

Overview of the pharmacovigilance inspection process (28Kb)

Types of inspections
There are three types of inspections:

1. Routine national inspections: these are scheduled inspections that UK market authorisation holders (MAHs) undergo on a periodic basis. MAHs are notified of these inspections in advance. These inspections are generally systems based, meaning that inspectors examine the systems and procedures used by a MAH to comply with existing EU and national pharmacovigilance regulations and guidance.
2. 'For cause' national inspections: these are ad-hoc inspections that are triggered as a result of, for example, safety issues, suspected violations of legislation relating to the monitoring of the safety of medicines, referrals by other Member States. In rare circumstances, MAHs may not be notified of these inspections in advance.
3. Committee on Human Medicinal Products (CHMP) requested inspections: the CHMP may request inspections of MAHs in association with specific centrally authorised products. These can either be routine or triggered. The general organisation and process for CHMP-requested pharmacovigilance inspections is described in Volume 9A, Part 1, Section 2.4. The procedures for EU pharmacovigilance inspections requested by the CHMP can be found on the EMEA website (external link).

In some circumstances, non-UK sites may be subject to inspection if they are involved in monitoring the safety of medicines marketed in the UK/EU. This can be at a national or EU level.

Actions required by MAHs following notification of an inspection
Following notification of the intent to perform a pharmacovigilance inspection, it is recommended that the MAH contacts the lead inspector (either by email or via the main MHRA switchboard - contact details below) as a precautionary measure to ensure the notification is genuine, due to the potential for impersonation of MHRA staff.

MAHs are required to complete and submit a Summary of Pharmacovigilance Systems (SPS) document (198Kb) before the inspection takes place. The SPS provides information to assist both the MAH and the inspectorate in preparing for the inspection. Additional documents may also be requested as appendices to the SPS. Please refer to our guidance notes (102Kb) for help completing the SPS document.

The inspections themselves consist of site visits during which interviews, document and computer system reviews (including searches of any pharmacovigilance databases) are performed.

Grading of inspection findings
Deficiencies found during Inspections are graded in one of three ways:

• Critical: a deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines.
• Major: a deficiency in pharmacovigilance systems, practices or processes that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines.
• Other: a deficiency in pharmacovigilance systems, practices or processes that would not be expected to adversely affect the rights, safety or well-being of patients.

Some common inspection findings and current areas of concern that have been identified during recent inspections, together with some examples (386Kb)



Inspection report and company response process
Once the inspection has been completed, an inspection report is prepared by the lead inspector, usually within 30 days of either the last site visit, or receipt of the last document requested, which ever is later. It should be noted that the factual matter contained in the inspection report relates only to those things that the inspection team sees and hears during the inspection process. The inspection report is not to be taken as implying a satisfactory state of affairs in documentation, premises, equipment, personnel or procedures not examined during the inspection.

The MAH is requested to provide responses to inspection findings within 30 days of the report being issued. Guidance on responding to inspection findings is available below:

Responding to inspection findings (393Kb)

Referral to Pharmacovigilance Inspection Action Group (PIAG)
Critical findings are routinely referred to the MHRA’s Pharmacovigilance Inspection Action Group (PIAG). This is a non-statutory, multi-disciplinary group constituted to advise the Director of Inspection and Standards, the Director of Post Licensing and the Director of Licensing on any recommendation for referral or enforcement action appropriate to the divisions, which arises from non-compliance detected during pharmacovigilance inspections. PIAG provides advice in cases where critical findings are identified during inspection and/or serious non-compliance is identified that could affect the rights, safety or well-being of patients.