Regulatory Open Forum

I'm currently looking to restructure my company's GxP retention schedule based on GxP doc type retention periods. For example, we will have categories for GLP, GCP, GMP, and GVP (further defined by doc type, to which appropriate retention periods are assigned based on country-specific regulations). However, we also have categories of documents, including Regulatory and QA, which overlap several GxP areas. Such regulatory documentation includes categories like regulatory correspondence, investigational drug, approved drug, non-product correspondence, Drug Establishment, and non-human safety reporting. To keep the schedule GxP-specific, I'd rather not retain "Regulatory" and "QA" retention categories outside of the main GxP groups. Has anyone else dealt with a similar grouping situation, and did you end up breaking up this type of Regulatory/QA documentation into separate GxP groups? In your experience, is a GxP-structured schedule the most efficient means of organizing document types for retention?

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Kelsey Dorwart
Boston MA
United States
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Kelsey,

What a practical question!

I would recommend you assign retention period globally applicable to all document types rather than specific document types when it comes down to docs that fall under "Quality Management Systems" in accordance with the ISO 13485 and/or 21 CFR Part 820.

As an example:  

Under the umbrella QMS
- all GxP docs fall
- Product -> Study Types -> GxPs
- Retention period for study files under GxPs -> 30 Years

You may choose to keep some RA docs separate from the QMS.

As for GxP docs, we can/may have electronic copies. Nowadays, it is easier to keep them almost permanently.  As the society becomes more litigious, it should be the firm's best interest to keep quality-related docs as long as reasonably possible (15-30 years or even longer).  

Exception: some docs may need to be chosen to destroy after a minimum of retention period according to applicable legal requirements.

Of course, you don't have to fight against the wall if the management opposes to your good, innocent intention and suggestion similar to mine.  

Your job is done when you complete your suggestion to the management in a clear, definite manner!

I am open to further suggestions!


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Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 02-25-2015 10:42
From: Kelsey Dorwart
Subject: GxP-Structured Retention Schedule Organization

I'm currently looking to restructure my company's GxP retention schedule based on GxP doc type retention periods. For example, we will have categories for GLP, GCP, GMP, and GVP (further defined by doc type, to which appropriate retention periods are assigned based on country-specific regulations). However, we also have categories of documents, including Regulatory and QA, which overlap several GxP areas. Such regulatory documentation includes categories like regulatory correspondence, investigational drug, approved drug, non-product correspondence, Drug Establishment, and non-human safety reporting. To keep the schedule GxP-specific, I'd rather not retain "Regulatory" and "QA" retention categories outside of the main GxP groups. Has anyone else dealt with a similar grouping situation, and did you end up breaking up this type of Regulatory/QA documentation into separate GxP groups? In your experience, is a GxP-structured schedule the most efficient means of organizing document types for retention?

-------------------------------------------
Kelsey Dorwart
Boston MA
United States
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