III.B.2. Inspection planning

Pharmacovigilance inspection planning should be based on a systematic and risk-based approach to make the best use of surveillance and enforcement resources whilst maintaining a high level of public health protection. A risk-based approach to inspection planning will enable the frequency, scope and breadth of inspections to be determined accordingly.

In order to ensure that inspection resources are used in an efficient way, the scheduling and conduct of inspections will be driven by the preparation of inspection programmes. Sharing of information and communication between inspectors and assessors is important to ensure successful prioritisation and targeting of these inspections.

Factors which may be taken into consideration, as appropriate, by the competent authorities when establishing pharmacovigilance inspection programmes include, but are not limited to:

• inspection related:
  • compliance history identified during previous pharmacovigilance inspections or other types of inspections (GCP, GMP, GLP and GDP);
  • re-inspection date recommended by the inspectors or assessors as a result of a previous inspection;
• product related:
  • product with additional pharmacovigilance activities or risk-minimisation activities;
  • authorisation with conditions associated with safety, e.g. requirement for post-authorisation safety studies (PASS) or designation for additional monitoring;
  • product(s) with large sales volume, i.e. products associated with large patient exposure in the EU;
  • product(s) with limited alternative in the market place;
• marketing authorisation holder related:
  • marketing authorisation holder that has never been subject to a pharmacovigilance inspection;
  • marketing authorisation holder with many products on the market in the EU;
  • resources available to the marketing authorisation holder for the pharmacovigilance activities they undertake;
  • marketing authorisation holder with no previous marketing authorisations in the EU;
  • negative information and/or safety concerns raised by competent authorities, other bodies outside the EU or other areas (i.e. GCP, GMP, GLP and GDP);
  • changes in the marketing authorisation holder organisation, such as mergers and acquisitions;
• pharmacovigilance system related:
  • marketing authorisation holder with sub-contracted pharmacovigilance activities (function of the qualified person responsible for pharmacovigilance in the EU (QPPV), reporting of safety data etc.) and/or multiple firms employed to perform pharmacovigilance activities;
  • change of QPPV since the last inspection;
  • changes to the pharmacovigilance safety database(s), which could include a change in the database itself or associated databases, the validation status of the database as well as information about transferred or migrated data;
  • changes in contractual arrangements with pharmacovigilance service providers or the sites at which pharmacovigilance is conducted;
  • delegation or transfer of pharmacovigilance system master file management.

National competent authorities and the Agency may solicit information from marketing authorisation holders for risk-based inspection planning purposes if it is not readily available elsewhere.