Discounts This essential reference guide covers pharmacovigilance of medicinal products for human use. The Good Pharmacovigilance Practice Guide highlights the areas in which inspection findings are commonly found and provides specific examples of good or poor practice. This assists organisations in developing effective pharmacovigilance systems. This book complements EU legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance. It will also be of great interest to pharmacovigilance consultants. Contents include: roles and responsibilities of the EEA Qualified Person for Pharmacovigilance managing case reports and other safety information ongoing evaluation of safety data quality management aspects of pharmacovigilance managing contracts and agreements pharmacovigilance beyond the drug safety department.

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Types of inspection Inspections are typically scheduled by pharmacovigilance system than by MAH. A pharmacovigilance system is defined as the system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

If a group of associated MAHs share the same pharmacovigilance system, all MAHs may be included within the scope of a single inspection of that pharmacovigilance system.

Conversely, if an MAH operates more than one pharmacovigilance system, we usually review these through separate inspections. The MAH is usually notified of these inspections in advance. If an inspection results in a critical finding it is likely the MAH will be subject to a triggered re-inspection within 12 to 18 months, with a focus on the actions that were agreed following the last inspection.

If no critical findings are identified there is no specific timeline by which an MAH must be inspected again. The frequency of inspection will be decided using the risk-based approach, and an inspection may be performed at any time.

As of , we no longer require routine GPvP compliance reports to be submitted by MAHs, which were previously used to inform our risk-based inspection programme, as we now have access to a variety of information sources that can support our scheduling and planning activities. Occasionally, an organisation may be specifically requested to provide information relating to their authorisations and pharmacovigilance systems.

EU inspections The European Medicines Agency EMA co-ordinates a programme of inspections for pharmacovigilance systems that include centrally authorised products. The programme is based on a routine four-yearly cycle adopted by the Committee on Human Medicinal Products CHMP , however, the outcome from national risk assessment may lead to a more frequent scheduling of inspections. The conduct of these inspections typically follows the same approach as for routine national inspections.

We may send little or no notification of these inspections in advance. The supervisory authority for the inspected organisation will typically lead such an inspection. Often, inspections are requested by CHMP to address a specific issue that may concern more than one national competent authority, and therefore the supervisory authority may be supported by other authorities in the inspection.

The inspection site may be in a non-EU country dependent on the scope of the inspection and the primary location of pharmacovigilance activities conducted by the MAH. Service Provider inspections Increasingly, MAHs are outsourcing all or some of their pharmacovigilance activities to contract service providers; such activities conducted by these organisations on behalf of MAHs are subject to supervision by MHRA , including by means of inspection.

Following a pilot programme of stand-alone service provider inspections, we concluded that a routine programme of inspections of pharmacovigilance service providers is not currently viable for MHRA GPvP inspectorate.

We continue to assess the activities performed by service providers in the context of MAH inspections. We may conduct stand-alone inspections of these organisations where it is deemed necessary to evaluate the overall system and procedures implemented by a service provider based on risk information available to MHRA.

Contracts with pharmacovigilance service providers should include provisions that cover the availability of data, documentation and appropriate support to the MAH and inspectors during a GPvP inspection. This information is taken account of when planning our inspections. As part of the inspection notification, the pharmacovigilance system master file PSMF will be requested. You must acknowledge you have received the notification and provide details of the relevant contact person for future correspondence about the inspection.

If you have concerns about the authenticity of a notification, contact gpvpinspections mhra. In addition to the PSMF , inspectors may require supplementary information to confirm the scope of the inspection and to be well prepared. The lead inspector will explain how our document request system works. MAHs can expect to receive requests for documentation prior to the inspection and throughout. Where substantial document review is required prior to the inspection, inspectors may incorporate remote inspection time in to the inspection plan.

We expect any documents listed in the PSMF to be readily available for inspection. This includes but is not limited to : procedural documents such as SOPs, working instructions and guides outputs from pharmacovigilance activities such as safety review meeting minutes documented product safety reviews agreements in place with partners and service providers Inspection location To achieve the objectives in reviewing the pharmacovigilance system, inspectors will aim to be flexible with the plan and to accommodate changes as required, if possible.

It is always preferable to conduct face to face interviews, however the inspection team can accommodate interviews by telephone if interviewees are unable to attend the site, provided facilities are adequate to support this.

If the MAH does not have a UK site and is using a vendor site or hiring office space for the inspection, consideration should be taken to ensure access to WIFI and teleconference facilities if required throughout the inspection, as well as prompt access to printing and copying facilities, and access to all electronic documentation and systems including the live safety database.

Remote inspections Routine and triggered inspections may be conducted by inspectors remotely. These inspections are conducted through review of requested documents including evidence to support pharmacovigilance activities and submissions. The document review is supplemented with telephone interviews with relevant subject matter experts and written responses to specific queries. Logistical aspects of the inspection, including timings and availability of specific subject matter experts and the QPPV for telephone interview, are arranged with the inspected organisation prior to the inspection.

An onsite inspection may be triggered following the remote inspection, should any significant non-compliance or concerns that require further investigation be identified.

Under UK law, an inspector acting on behalf of MHRA as competent authority has the right, at any reasonable time, to enter premises not limited to those of the MAH to determine if there has been a contravention of the regulations laid out in SI No per Regulation and the right to inspect information and documents relating the requirements for pharmacovigilance laid out in Part 11 of SI No as per Regulation In this instance, on arrival at site the lead inspector will identify the most appropriate person on site as a point of contact and will explain the purpose and logistics of the inspection.

The inspection During an inspection the inspection team will: conduct site visits review documents carry out computer system reviews including searching pharmacovigilance databases The inspection team will ask for additional documentation during the inspection. They may also change the focus of the inspection if they suspect serious non-compliance. The team and inspection duration Inspection teams are comprised of between one to four inspectors, spending between two and five days on site.

This can vary based on type of products marketed by the company, the complexity of the pharmacovigilance system and the type of inspection for example routine, triggered, or requested by CHMP.

Occasionally observers may also be present at our inspections. The PSMF is used as a tool in determining the resource required to perform the inspection, however this can be subject to change and inspections may be extended at short notice based on arising issues. Extension to inspections may take the form of office-based review of documentation following the on-site inspection, or a return to the inspection site for additional days. This would be communicated to the MAH at the time along with the rationale for extending the inspection.

Inspection conduct Inspectors normally interview operational personnel that are involved in pharmacovigilance activities or activities associated with pharmacovigilance including regulatory affairs, and management of post-authorisation safety studies. If considered necessary, for example if serious issues are identified relating to a business area, it might be necessary to interview a senior executive and senior executive s might be requested to attend the closing meeting.

The inspectors typically discuss issues with the MAH as they arise during the inspection to allow for clarification. At the closing meeting the inspector will provide feedback and discuss any deficiencies and actions required after the inspection with the MAH. Inspection fees.


Good pharmacovigilance practice for medicines (GPvP)



Good pharmacovigilance practice (GPvP)


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