After the inspection, a report of the findings is issued to the MAH

1. A preliminary notification to the Marketing Authorisation Holder (MAH) of statutory inspection is sent to the organisation, which includes a request for the Summary of Pharmacovigilance Systems (SPS) The inspection plan is developed with the MAH and finalised The inspection dates are confirmed with the MAH MAH supplies the SPS PLANNING Where critical issues are found these are routinely referred to the Pharmacovigilance Inspection Action Group (PIAG) Main inspection of the MAH takes place (to include contract organisation, external consultants, if applicable) – if the MAH is represented in the UK by a Distributor this may be the location of the inspection INSPECTION The MAH provides responses to findings (which must be approved by the EEA QPPV) and the Corrective Action, Preventative Action (CAPA) plan is reviewed for acceptability* Once CAPA acceptable, an inspection closing letter is issued* After the inspection, a report of the findings is issued to the MAH REPORTING * If findings are referred to PIAG, non-routine post-inspection actions may be taken in addition to the review of the CAPA and the provision of a closing letter Last updated 04Feb08