INOPP Forum
MHRA GPVP Inspections
Quote from VigiServe Admin on January 16, 2021, 7:28 AMGood Pharmacovigilance Practice (GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the UK.
The MHRA inspects marketing authorisation holders (MAH) to determine whether they comply with pharmacovigilance obligations established within the UK. The MHRA has been conducting statutory GPvP inspections since 2003, and any UK MAH or marketing authorisation applicant (for any authorisation procedure) can be subject to GPvP inspection by MHRA, which may also include any of their partners or service providers.
If pharmacovigilance activities are performed outside the UK, the MHRA may ask company personnel from other country sites to participate in an inspection at a UK site and/or may liaise with inspectorates in other regulatory agencies to perform an inspection at the site(s) in their country or to share results from recent inspections, where confidentiality agreements are in place.
Types of inspection
- Routine national inspections
- Triggered inspections
- Pre-authorisation inspections
- Service Provider inspections
Pre-inspection documents
Prior to the inspection the lead inspector will contact the MAH and QPPV and provide the draft plan as well as any specific requirements of the team. 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 into the inspection plan.
MHRA expects 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 and documented product safety reviews
- audit risk assessments
- agreements in place with partners and service providers
Good Pharmacovigilance Practice (GPvP) is the minimum standard for monitoring the safety of medicines on sale to the public in the UK.
The MHRA inspects marketing authorisation holders (MAH) to determine whether they comply with pharmacovigilance obligations established within the UK. The MHRA has been conducting statutory GPvP inspections since 2003, and any UK MAH or marketing authorisation applicant (for any authorisation procedure) can be subject to GPvP inspection by MHRA, which may also include any of their partners or service providers.
If pharmacovigilance activities are performed outside the UK, the MHRA may ask company personnel from other country sites to participate in an inspection at a UK site and/or may liaise with inspectorates in other regulatory agencies to perform an inspection at the site(s) in their country or to share results from recent inspections, where confidentiality agreements are in place.
Types of inspection
- Routine national inspections
- Triggered inspections
- Pre-authorisation inspections
- Service Provider inspections
Pre-inspection documents
Prior to the inspection the lead inspector will contact the MAH and QPPV and provide the draft plan as well as any specific requirements of the team. 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 into the inspection plan.
MHRA expects 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 and documented product safety reviews
- audit risk assessments
- agreements in place with partners and service providers