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  • 1.  Qualification of suppliers

    Posted 18-Feb-2016 16:25

    I have a two questions regarding 231 CFR 211.84(d)(2) which is stated below:

     

    Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures.

    (d) Samples shall be examined and tested as follows:

    (2) Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier's analyses.

     

    Question 1) What does "component" refer to?  Does this apply to APIs and excipients?  Or is this only for packaging components?

    Question 2) How do manufacturers "establishes the reliability of the supplier's analyses"?  Is this typically done by fully testing one lot of API/excipient per year?  Is the 1 lot/year a GMP requirement?

     

    Thank you.

    Tom

    Chicago, IL



  • 2.  RE: Qualification of suppliers

    Posted 18-Feb-2016 18:34
    Tom,

    "Question 1) What does "component" refer to?  Does this apply to APIs and excipients?  Or is this only for packaging components?

    The term "component" should be interpreted as any ingredient intended for use in the manufacture per 21 CFR 210.3(b)(3). (21 CFR Part 211 in PDF here)  

    "Question 2) How do manufacturers "establishes the reliability of the supplier's analyses"?  Is this typically done by fully testing one lot of API/excipient per year?  Is the 1 lot/year a GMP requirement?"

    First, you should establish your risk-based "Supplier Qualification Program", describing how you would qualify your suppliers. 

    Simply put, you may require a Certificate of Analysis certified each and every time so that you can simply visually inspect the products/services that you receive per your signed "Quality Agreement."  

    Otherwise, you can implement whatever tests are needed to ensure that suppliers meet your needs. You also may audit selected suppliers at intervals with sufficient frequency.  Depending upon the potential risks, you may perform a desk audit or present quality audit questionnaire. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 3.  RE: Qualification of suppliers

    Posted 19-Feb-2016 07:56

    Hi Tom.

    My first thought here is simple.  With regard to question 1 if you notice the regulation specifically notes drug product containers and closures as well as the components.  Therefore, I would interpret that as meaning that the "component" in the regulation means the ingredients.  I believe that there may also be a definition of component in the regulation but I haven't specifically looked for this currently.

    As for question 2, this is a bit more work.  I would agree with David that you need to understand and map out a reasonable risk-based program before even trying to start on shortening your testing requirements and simply accepting COA values.  What this means is different for every company and could be different for different types or classifications of product.  For example, if I have a parenteral drug, I may consider far more work being necessary than if it is topical.  And if it is a "direct instillation" ocular drug I might want more data to verify my supplier COA than if it is oral.  However, what I have generally seen done at a minimum is full testing to confirm supplier COA data for all parameters for three separate lots to begin with and then a minimum of 1 lot full tested per year.  Now, if it is your API, you might make your identification test whatever the analytical assay is for the material.  This would allow you to ensure that you are aware of any possible degradation products in the material when it enters the company's control.  For an excipient, you could do something more simplistic so long as any issue with the excipient is not expected to cause significant deterioration of the product compared to its specification or stability.

    Hope some of this helps!

    ------------------------------
    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    Hain Celestial Group
    United States

    Original Message


  • 4.  RE: Qualification of suppliers

    Posted 22-Feb-2016 10:40

    Thank you David and Victor for your feedback.  Very much appreciated.

    Tom




    Original Message