Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hello,

I'm currently working on a Japanese QMS Inspection application in accordance with Ministerial Ordinance No. 169 (revised in 2014). I've been told that the ordinance mandates the primary manufacturer (Or Marketing Authorization Holder "MAH") to submit audit reports (redacted versions are accepted) issued by audits conducted by government bodies, such as US FDA, European Notified Bodies, etc.  The scope of audit reports not only include the MAH, but also includes contract/sterilization facilities that the MAH might have agreements with.  The idea behind submitting audit reports is to mitigate the chance of an on-site inspection by PMDA., as opposed to just a desktop inspection.

Due to the nature of these documents, I've received  push back from some companies. Has anyone experienced something similar? If yes, I would greatly appreciate any feedback on how you may have handled the situation.

Thank you.

I have had some experience with this issue. Some companies have been willing to email the audit reports directly to PMDA. Try that, but first check with PMDA as they may have a special header document the company would need to submit with their audit report to identify it as being part of your submission.

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Saliane Anderssen
Regulatory Affairs
United Kingdom
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Original Message:
Sent: 15-Mar-2018 16:28
From: Anonymous Member
Subject: Japanese QMS Inspection Application

This message was posted by a user wishing to remain anonymous

​Hello,

I'm currently working on a Japanese QMS Inspection application in accordance with Ministerial Ordinance No. 169 (revised in 2014). I've been told that the ordinance mandates the primary manufacturer (Or Marketing Authorization Holder "MAH") to submit audit reports (redacted versions are accepted) issued by audits conducted by government bodies, such as US FDA, European Notified Bodies, etc.  The scope of audit reports not only include the MAH, but also includes contract/sterilization facilities that the MAH might have agreements with.  The idea behind submitting audit reports is to mitigate the chance of an on-site inspection by PMDA., as opposed to just a desktop inspection.

Due to the nature of these documents, I've received  push back from some companies. Has anyone experienced something similar? If yes, I would greatly appreciate any feedback on how you may have handled the situation.

Thank you.