News about GMP/cGMP

28.01.2021

PMDA: Information on the procedure for remote inspections

PMDA: Information on the procedure for remote inspections

In January 2021, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published the English translation of the document on remote inspections, Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products.


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:

  1. The PMDA announces the inspection to the applicant as a remote inspection; if necessary, there is a pre-inspection meeting.
  2. 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.
  3. The applicant grants the inspector access to the cloud system or sends the documentation on CD or DVD to PMDA.
  4. Information on sampling condition/scope of documentation will be provided to the applicant 13 business days prior to the main inspection.
  5. Within 10 business days prior to the main inspection, the applicant shares the documentation with the inspector(s).
  6. 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.
  7. 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.
  8. 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 


 

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