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  • 1.  document retention

    Posted 21-Feb-2013 08:14
    Does anyone know guidance document for 'documents retention", " record keeping" or any kind of SOP exist could you please share link for those documents.

    thanks in advance

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    Amit Jain
    Tedor Inc.
    Cumberland RI
    United States
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  • 2.  RE:document retention

    Posted 22-Feb-2013 02:45
    The best compilation I know of, which has also been reviewed by FDA and EMA is the ISPE GAMP Good Practice Guide on Electronic Data Archiving, August 2007 - www.ispe.org
    Regards
    Siegfried
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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 3.  RE:document retention

    Posted 22-Feb-2013 08:19
    This is an excerpt from the FDA Medical Device Quality System Manual - Small Entity Compliance Guide
    Record Retention

    The QS regulation in section 820.180(b) requires that all records pertaining to a device shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer. Manufacturers of long­life products should make prudent decisions as to how long to keep records. For example, there may be no value in keeping records for long­life devices such as stretchers, surgical tools, containers, etc., forever if the probability is low that any post­distribution remedial activity will occur. For devices that require repair or capital equipment devices that probably will be updated, appropriate records should be retained to support these repairs or modifications.

    Device master record requirements apply to devices modified in the field by the manufacturer's representatives after the devices are commercially distributed. Modification of a device is manufacturing and the QS regulation covers all manufacturing of devices where the result is placed into commercial distribution. In any case, a manufacturer should be prepared to provide a rationale for its decision to discontinue record-keeping. 
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    Michael Zagorski RAC
    Director of Q&R
    Sway Medical LLC
    Pittsburgh PA
    United States
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    Original Message


  • 4.  RE:document retention

    Posted 22-Feb-2013 10:58

    Depending on your products and the type of documents, the required retention time can be different. I suggest you go to the relevant CFR sections to find the minimum record retention requirements for your situation. You will also need to comply with your institutional requirements, as well as foreign country regulations if your products/studies are marketed/conducted in other countries.  For instance, a clinical drug conducted by NIH investigator un an IND will need to comply with both the NIH requirement (three year after study is completed or closed) and the FDA requirement under 21 CFR 312.57 and 21 CFR 312.62 (two years after marketing application is approved). The rule of thumb is to go with the most stringent requirement for your record keeping.  

    Hope it helps.

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    Xiaowei Wang RAC
    Product Coordinator/Manager
    NIAID
    Boyds MD
    United States
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    Original Message


  • 5.  RE:document retention

    Posted 22-Feb-2013 11:00
    Hello Amit,

    As per 21 CFR subpart J Records & Reports, 1 year after product expiry shall be the retention time of records and for certain OTC drugs which doesn't have expiry it shall be 3 years from the date of distribution of particular lot.  However ADE records shall be retained for 10 years after the date of event occurrence.
    Below are list of few documents but not limited.
    • Batch Manufacturing records, Batch packaging records, Process validation  records.
    • Equipment & maintenance logs and calibration documents, laboratory records  (Validation & Verification reports, Lab note books & raw data).
    • Control records for raw material (active, inactives, product containers and closures), labeling documents.
    • Complaint files, Recalls, return good records, Change controls, Annual product review,  and any other document as per QA recommendations.
    • Disposition records.

    Regards,
    Sireesha Alla
    PolyGen Pharmaceuticals
    NY, USA


     





    Original Message


  • 6.  RE:document retention

    Posted 22-Feb-2013 11:55
    Hi Amit,

    Document retention requirements vary by geography and type of product. Are you looking for EU, US, Canadian, etc. requirements or just one geography? What kinds of products are you concerned about? Does your company already have an existing records retention SOP?

    The answers to these questions will help us help you.

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    Paula Bojsen
    Global Regulatory Compliance Manager
    Ranir, LLC
    Grand Rapids, MI
    United States
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    Original Message


  • 7.  RE:document retention

    Posted 22-Feb-2013 14:32
    I'd like to thank everyone, It has certainly been eye-opening comparing the answers with each other as well as to information received in response to a direct inquiry from the FDA.

    Again thanks to everyone for your thoughtful and helpful responses.


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    Amit Jain
    Tedor Inc.
    Cumberland RI
    United States
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    Original Message