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  • 1.  Un-labelled Vials for Commercial Labeling,

    This message was posted by a user wishing to remain anonymous
    Posted 30-Aug-2022 09:41
    This message was posted by a user wishing to remain anonymous

    Dear Members,

     

    Your comments are highly appreciated  highly, for the following question:

     

    We like to send the unlabeled final product in vials for the commercial primary labeling, secondary Cartoning and final carton labeling.

    The filled, capped, crimped and inspected vials are packaged into bulk cartons and labeled with product/batch (inside & out).

    Each product is shipped individually in tertiary cold chain packaging to avoid mix-up between lots and/or products.

     

    I am looking for direction to regulations, if I have to label the individual vials for shipment.



  • 2.  RE: Un-labelled Vials for Commercial Labeling,

    Posted 31-Aug-2022 05:04
    Hello Anon,

    I was trying to find the exact reference to this, but generally it can be accepted to transport unlabelled product from one location to another location for final labelling and packaging.  There are labelling requirements on the containers which needs to be clearly stated and this process is strongly supported by saying the traceability and control of these unlabelled products needs to be highly managed.  I am not sure specific to drug products, but on the medical device side in 21 CFR 801 talks about exemptions of labelling.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Un-labelled Vials for Commercial Labeling,

    Posted 06-Sep-2022 13:54
    I don't know of specific regulations that say it is OK, but it is standard practice. The one area where this practice has caused a bit of a hassle is in satisfying the CFR requirement for ID testing of biologics:

    § 610.14 Identity.

    The contents of a final container of each filling of each lot shall be tested for identity after all labeling operations shall have been completed. The identity test shall be specific for each product in a manner that will adequately identify it as the product designated on final container and package labels and circulars, and distinguish it from any other product being processed in the same laboratory. Identity may be established either through the physical or chemical characteristics of the product, inspection by macroscopic or microscopic methods, specific cultural tests, or in vitro or in vivo immunological tests.



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    Rachel Thornton
    Associate Director
    Smyrna GA
    United States
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    Original Message


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