MDSAP Regions and how to include in procedures

#1
I am having an issue where during an internal audit I have discovered an Incomplete CAPA from last year. The initiator has determined via a MDSAP finding that references to external standards (EU, US, Japan, etc) were missing or being made inconsistently in some of our SOP's. The SOP's have been updated earlier this year and I do not have easy access to the old drafts.

My question is how can I determine if the new revisions of the procedures are properly referencing the external "regional" standards without looking at older revisions? I can't ask the CAPA initiator as they have left the company and I have only been with the current company for a month.

I need to figure out if we are currently referencing standards correctly or if we are still not compliant.
 
Elsmar Forum Sponsor
#2
First, can you clarify why you can't contact the CAPA initiator? We had a nasty split from our joint venture partner (5 years of nasty litigation) but the regulatory/quality folks from both sides all got along and still occasionally call upon one another. They're probably still under some kind of confidentiality obligation and asking questions isn't a breach of confidentiality, typically. Even if they hate the company, they may still show you mercy provided you take the right approach.

Second, can you also confirm that the references were only missing/inconsistent and not incorrect? (i.e. even if you found the old revisions, could you rely upon their correctness, if not their completeness and consistency? And further, could you be confident that any new references to regional standards were now complete?)

From my perspective, it would be good to have the old procedures but not strictly necessary as you can ensure the SOPs are compliant by undertaking a de novo (not sure that is the correct lingo) approach.

But please note I'm out of my element here on this sunny Friday afternoon.
 

yodon

Staff member
Super Moderator
#3
It sounds like you're saying current versions of controlled documents of external origin weren't being used / referenced. There should be someone in the organization who is responsible for maintaining the list of these types of documents and periodically seeing if they are the latest (there are services for purchase to alert you to updates to many of these docs). Can you get with those individuals and have them show you what's latest (and why they believe that's the case)?

I'm not sure that access to old drafts (unreleased) would be helpful but do you have access to previous revisions of the SOPs? That's basic Doc Control. If you don't, there are some fundamental issues that need to be corrected.
 
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