The document describes the specific procedure for a remote inspection in five points. A further four points clarify how to proceed with the necessary documents. Three points deal with the video conferencing system in more detail.
The procedure is usually as follows:
- The PMDA announces the inspection to the applicant as a remote inspection; if necessary, there is a pre-inspection meeting.
- The PMDA confirms the schedule of the pre-inspection and the method of presenting documentation approximately one to two months prior to the main inspection.
- The applicant grants the inspector access to the cloud system or sends the documentation on CD or DVD to PMDA.
- Information on sampling condition/scope of documentation will be provided to the applicant 13 business days prior to the main inspection.
- Within 10 business days prior to the main inspection, the applicant shares the documentation with the inspector(s).
- A pre-inspection, during which the documents are checked, takes place within 10 business days; if there are any concerns to be examined, the applicant is informed.
- During the main inspection using a video conferencing system, documents that could not be reviewed during the pre-inspection will be reviewed and the applicant will be interviewed about the concerns identified during the pre-inspection.
- After the inspection, the applicant should take action on the unresolved concerns as soon as possible.
PMDA: Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical product