For the scope of a re-inspection, the following aspects should be considered:
• review of the status of the system and/or corrective and preventive action plan(s) resulting from previous pharmacovigilance inspection(s);
• review of significant changes that have been made to the pharmacovigilance system since the last pharmacovigilance inspection (e.g. change in the pharmacovigilance database, company mergers or acquisitions, significant changes in contracted activities, change in QPPV);
• review of process and/or product-specific issues identified from the assessment of information provided by the marketing authorisation holder, or not covered in a prior inspection.
The scope of re-inspection will depend on inspection history. It may be appropriate to conduct a complete system review, for example, if a long time has elapsed since the previous inspection
For the scope of a re-inspection, the following aspects should be considered:
• review of the status of the system and/or corrective and preventive action plan(s) resulting from previous pharmacovigilance inspection(s);
• review of significant changes that have been made to the pharmacovigilance system since the last pharmacovigilance inspection (e.g. change in the pharmacovigilance database, company mergers or acquisitions, significant changes in contracted activities, change in QPPV);
• review of process and/or product-specific issues identified from the assessment of information provided by the marketing authorisation holder, or not covered in a prior inspection.
The scope of re-inspection will depend on inspection history. It may be appropriate to conduct a complete system review, for example, if a long time has elapsed since the previous inspection
