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Is there any guideline that old raw material documents (e.g. incoming material checklist, material release checklist) can be disposed of?

#Disposal #True copies

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Posted 25 March 2020 - 03:06 AM

Hi all.


Can anyone know if there is any guideline that old Raw material documents(i.g., incoming material checklist, material release checklist) can be disposed?


We have prepared the "True copy" Procedure, and will plan disposal of old documents such as raw material documents, retiree's GMP training binders.

Please let me know there is any guideline, for example PICS, ICH, FDA cGMP, saying document retention period.

I can't google retention period for these document types, so can't ensure disposal of these.

Edited by Joy ANN, 25 March 2020 - 03:11 AM.


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Posted 25 March 2020 - 11:21 AM

Hi Joy Ann


As a starting point I would check what your quality standard (if you are accredited) requires, and also your customer specific requirements.


Our manufacturing sites are BRC V8 accredited – clause 3.3.2 of this standard requires that records are maintained for product shelf life + 12 months as a minimum, but also that customer requirements are considered.  As we manufacture ambient stable products with a maximum life of 18 mths this would be 18mths + 12mths = 2.5 years, but one of our customers requires 4 years for record retention, so we default to record/document retention for all  quality related documents to 4 years (as it is not practical to separate records for this specific customer).


Assuming you are working to a document control system (if the site has 3rd party accreditation), this should detail which procedures/documents/records are current and when the older versions were archived.


Note that your financial records may be covered by a different piece of legislation (such as JSOX) and would be outside the scope of the quality documentation system.


This FDA link may be useful:  https://www.accessda....cfm?fr=117.315


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Posted 27 March 2020 - 02:01 PM

Risk assessment identifying any potential "hazard" of destroying them at shelf life, 2 years, 3 years etc. The time frame is up to you if there are no governmental regulations controlling it. It needs to be adequate to eliminate any potential food safety hazards. Just be sure you can back up your decision.

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