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  • 1.  Use of non-GMP starting material for API manufacture

    Posted 10-Dec-2014 16:47
    Hi all,

    Is there any way to use materials produced in an R&D lab (non-GMP) as starting materials for API manufacturing. And if so, what sort of tests would be required to quality such materials for said purpose? Any help with clarifying would be appreciated.
    Thanks.

    Regards,
    Sergei Poletaev 


  • 2.  RE: Use of non-GMP starting material for API manufacture

    Posted 11-Dec-2014 10:32
    Hi Sergei,

    Starting materials for API often times are produced non-GMP. I think it is entirely possible to use material from R&D lab as starting material for GMP API manufacturing. 

    I assume here that your API will be used in human. Is your API going to be used in early stage development (i.e. Phase 1) vs later stage? Other than your company's quality philosophy/conservativeness, the phase of development greatly affects how stringent your documentation and analytical testing will be. As a start, FDA's Guidance for Industry: cGMP for Phase 1 Investigational Drugs provides some information on the view of the agency (well at least the FDA) for Phase 1 drug.

    If this is for Phase 1, I would expect good description of the procedure, raw materials, reagents, and solvents used. Collecting all the CoAs is a good practice but one should, at least, record all the suppliers and lot numbers. The key is to have some traceability of materials. Analytical methods for starting materials are likely not the most sophisicated especially at early stage, but they should give you confidence on the identity and purity of the starting material going into the GMP API manufacturing (hard to pin point the analytical techniques to use because that depends on your material). 

    Hope it helps. Happy to discuss more.

    -------------------------------------------
    Priscilla White RAC
    Associate Director, Pharmaceutical Development
    Infinity Pharmaceuticals, Inc.
    Cambridge MA
    United States
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    Original Message


  • 3.  RE: Use of non-GMP starting material for API manufacture

    Posted 11-Dec-2014 18:31
    Hi Sergei,

    This is complicated; Please refer to ICHQ7A GMP Guidance for Active Pharmaceutical Ingredients and Guidance for Industry Drug Substance CMC information August 6, 2010. Note definitions for starting materials and difference between small molecules and biologics.  

    Good luck,

    Dar 

    -------------------------------------------
    Darlene Rosario RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 4.  RE: Use of non-GMP starting material for API manufacture

    Posted 31-Dec-2014 16:12
    Thanks to everyone for the input. I apologize for not following up on your responses sooner - I couldn't locate this thread after I posted it (this is my first posting on the RAPS forum and I'm still learning how to use it)

    -------------------------------------------
    Sergei Poletaev
    Quincy MA
    United States
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    Original Message