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  • 1.  Drug Raw Materials - cGMP Required?

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jul-2018 15:16
    This message was posted by a user wishing to remain anonymous

    ​​Hello,

    Is cGMP manufacturing required for raw materials (non-API) going into an NDA drug product? Due to the rarity of the material, it has been a challenge finding a supplier that can make it and that is cGMP compliant.

    Thanks!


  • 2.  RE: Drug Raw Materials - cGMP Required?

    Posted 05-Jul-2018 08:54
    ​Hi A.

    Please note before I start that this is my personal opinion and I look forward to other thoughts on this issue as I have more than once fell into this situation.

    If we look at the definition of a "drug" in both the Act and the regulations established under the Act, the definition includes "and the components used to manufacture the drug product".  This in essence would seem to require that the regulations for drugs also apply to drug components (read as "raw materials").  So there is a technical argument that you would need to have the raw materials meet the cGMP standards as well as manufacturing the finished drug product under the cGMP standards.  So in my mind I think you need to be as diligent as humanly possible to try to find a supplier who can (and will) consistently produce the raw material under cGMP standards.

    That said, I do know that there are some things that are either so rare or that find their main utility in other industries (e.g. paints) that do not require the raw material produced under cGMP conditions.  In this situation I have always been an advocate of something you might call "cGMP at the door" where you initiate full cGMP compliance once the material enters your facility.  This means effectively that every lot of raw material gets tested to whatever specification you have developed (impurities, identity, strength, etc.) hopefully in consultation with the FDA or other regulatory agency overseeing your product and being able to prove that you are working with a manufacturing partner for your non-API that consistently will meet the expectations of the use and cGMP requirements.

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Drug Raw Materials - cGMP Required?

    Posted 06-Jul-2018 08:18
    ​For raw materials used as non-active excipients, there are no specific FDA regulations requiring that excipients be manufactured under GMP conditions.  There is a requirement that a manufacturer establish quality standards for using excipients in the final drug product formulation and the manufacturer must assure that excipients meets these standards.  Often times, USP and other compendia have established standards or specification for the use of excipients including impurity limits.  Also manufacturers are expected to qualify suppliers of raw materials to assure that the materials consistently meet quality standards and that each lot of material is tested to assure its identify and other quality specifications.

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    Michael Trapani
    Senior Consultant
    Monroe Township NJ
    United States
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    Original Message


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