Regulatory Open Forum

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  • 1.  Release Site

    Posted 19-Oct-2012 14:53
    Does anyone know of any FDA legislation as to what is required to make a facility and Drug Product Release facility?  Will an inspection be required?

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    Andrea Gosda RAC
    Associate Director CMC
    Clark NJ
    United States
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  • 2.  RE:Release Site

    Posted 19-Oct-2012 15:13
    Please refer to 21 CFR Parts 210-211.

    In particular, 

    Subpart C--Buildings and Facilities 
       § 211.42 - Design and construction features. 
       § 211.44 - Lighting. 
       § 211.46 - Ventilation, air filtration, air heating and cooling. 
       § 211.48 - Plumbing. 
       § 211.50 - Sewage and refuse. 
       § 211.52 - Washing and toilet facilities. 
       § 211.56 - Sanitation. 
       § 211.58 - Maintenance.

    Given your situated circumstances, other provisions may apply.  
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  • 3.  RE:Release Site

    Posted 19-Oct-2012 15:26
    I confess that the terms you are using are not familiar to me.  Could you provide more context as to what you mean by a "Drug Product Release facility?" 

    For example, are you talking about a facility that does testing to determine if a drug manufactured by a different company meets its release specifications?  Are you talking about drugs that are under NDAs or ANDAs or OTC drugs being sold under drug monographs?

    Thanks.

    ______________________________________________
    Michael A. Swit
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
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    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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