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  • 1.  What does it mean by Batch specific variation ?

    This message was posted by a user wishing to remain anonymous
    Posted 11-Jan-2018 08:31
    This message was posted by a user wishing to remain anonymous

    I have an approved dossier and pdt is under commercialisation in EU. There is some deviation found from approved mfg process or parameters during commercial manufacturing and the QP reccomends to file a batch specific variation to fullfill the deviation through EU post approval changes guidance.

    My questions is:
    What is this batch specific variation? is it a one time variation just to save the batch and avoid destruction?
    Should I need to wait for approval of the variation till batch release or distribution in EU?
    Should I conside its approval as life long approval on pdt? (Mean permanant change?)
    Any EU guidance that help me to understand more about this?


  • 2.  RE: What does it mean by Batch specific variation ?

    Posted 12-Jan-2018 05:20
    You'll find more information by  googling batch specific variation.

    ------------------------------
    Steve Binysh
    Acta Pharma Services Ltd
    RUISLIP
    United Kingdom
    ------------------------------

    Original Message


  • 3.  RE: What does it mean by Batch specific variation ?

    Posted 12-Jan-2018 08:07

    The intent of batch specific variations is to allow release of a batch that still has acceptable quality, safety, and efficacy, but for some reason does not fully comply with the registered process.  For example, a specified parameter, such as intermediate hold time, may have been exceeded, but test results support that the end product would still be appropriate for patient use.  Approval is needed before use of the batch.

     

    A batch specific variation is not meant to set precedent for the product – if the same hold time is exceeded on a later batch, a new batch specific variation would be needed.

     

    There's a nice blog entry about this at https://medregs.blog.gov.uk/2017/02/09/when-the-unexpected-happens-batch-specific-variations/ and related guidance info can be found at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/481616/Common_Scenarios___Supplementary_Guidance_Nov_15.pdf

     

    Best regards,

     

    Cathy

     

     

    Catherine M Anderson, PhD, RAC

    Senior Manager, Regulatory Affairs CMC

     




    Original Message


  • 4.  RE: What does it mean by Batch specific variation ?

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2018 10:02
    This message was posted by a user wishing to remain anonymous

    ​Dear Cathe,

    This is so very much useful information. Many thanks. I read the references shared by you also.
    Is there any standard timeline for approval of batch specific variation just not to lose shelf life of my product? Does all EU agencies accepts this?
    I am a FP manufacturer located outside EU. So, Can I release my batch from my manufacturing site but batch release will not happen from EU batch release site untill variation approval. Is that possible?
    Original Message


  • 5.  RE: What does it mean by Batch specific variation ?

    Posted 17-Jan-2018 06:09
    I believe the answer to your question 'I am a FP manufacturer located outside EU. So, Can I release my batch from my manufacturing site but batch release will not happen from EU batch release site until variation approval. Is that possible? " is Yes. 
    However, the responsibility for EU batch release falls to the QP and MA holder, rather than the FP manufacturer who's located outside the EU (and I assume the EEA too).  For this reason, I would also also ask the Qualified Person for their advice because s/he  will be responsible for batch release.

    ------------------------------
    Steve Binysh
    Acta Pharma Services Ltd
    RUISLIP
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: What does it mean by Batch specific variation ?

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jan-2018 09:15
    This message was posted by a user wishing to remain anonymous

    ​Dear Steve,

    I agree to your opinion to ask QP's advise. Thank you.
    Original Message


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