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  • 1.  GMP Storage for API

    Posted 13-Mar-2024 11:22

    I need a sanity check on GMP requirements for the storage of API. Specifically, must API be stored in a GMP-certified facility/environment? If so, can someone please share the regulatory citing or rationale? 



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    Reynaldo Roman
    York PA
    United States
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  • 2.  RE: GMP Storage for API

    This message was posted by a user wishing to remain anonymous
    Posted 14-Mar-2024 09:07
    This message was posted by a user wishing to remain anonymous

    Hi!

    What about: 21 CFR 211.80

    Β§ 210.3 Definitions.
    (b) The following definitions of terms apply to this part and to parts 211...
    (3) Component  means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.

    Β§ 211.80 General requirements.
    (a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed. 
    (b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination. 
    (c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection. 
    (d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).
    Just a thought!

    Original Message


  • 3.  RE: GMP Storage for API

    Posted 14-Mar-2024 09:41

    Thanks. This is helpful. I'm looking for something even more concrete. 



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    Reynaldo Roman
    York PA
    United States
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    Original Message


  • 4.  RE: GMP Storage for API

    Posted 14-Mar-2024 09:54
      |   view attached

    Reynaldo,

    Did a quick DSCSA Copilot chatbot message -see below - might help you find answers to your query on FDA regulations with GMP for API storage.

    --------------------------DSCSA Copilot -----------------------------------------------------------------------------------------

    It's free, no credit  card gimmicks, no acct set-up nor app store downloads - just  point and click then chat with FDA DSCSA Copilot on anything  FDA regulatory related.  https://tinyurl.com/4t335sa2    FDA DSCSA Copilot 

    -------------------------------------------------------------------------------------------------------------------------------------------------

    What are requirement from FDA with storage of APi?


    Bot aid:

    The FDA provides guidance on good manufacturing practices (GMP) for the storage of active pharmaceutical ingredients (APIs) 1. The guidance emphasizes the importance of quality management and the responsibilities of the quality unit in ensuring the proper storage of APIs 1. It covers various aspects such as the design and construction of facilities, utilities, containment, lighting, sanitation, and maintenance 1. Additionally, it addresses the storage of raw materials, intermediates, and finished APIs, including controls for receipt, quarantine, sampling, testing, re-evaluation, and warehousing procedures 1. The guidance also highlights the need for proper documentation and records, including equipment cleaning and use records, batch production records, and laboratory control records 1. It is important for manufacturers to follow these guidelines to ensure the quality and integrity of APIs during storage 1

    1 reference 

    1

    Guidance for Industry, Q7A Good Ma



    ------------------------------
    Ram Balani
    CEO-Founder
    eSTARHelper LLC www.estarhelper.com
    Amawalk, New York
    rbalani@estarhelper.com
    2019130558
    www.estarhelper.com
    ------------------------------

    Original Message


  • 5.  RE: GMP Storage for API

    Posted 14-Mar-2024 10:09

    This is great. Thanks!!! 



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    Reynaldo Roman
    York PA
    United States
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    Original Message


  • 6.  RE: GMP Storage for API

    Posted 14-Mar-2024 11:36

    Sure thing Reynaldo. Glad I could help-am sure the chatbot will appreciate that πŸ€–

    Note:

    On the Copilot-- If you stump the chatbot  when messaging something it can't respond to  for any FDA  regulatory intelligence (drugs, biologics or medical devices) - just enter 'verify' the message  to the chatbot box--

    and then  choose 'verifywithsmartsearch' - follow instructions to log-in  to SmartSearch+ with

     User Name: guestsearch@yahoo.com and Password: helpdscsa$   .....to access SmartSearch+.(* Free, no gimmicks)

    SmartSearch+ is a full-text keyword search on ACTUAL FDA.Gov contents we host. If the FDA publishes it, -you'll find it without AI/ML ChatGPT-4 bias or hallucinations!

    This short  3-min video shows you how it works on my Samsung mobile - give it a test-run, ping me if you need help.

     http://tinyurl.com/278p3mwz 

    Happy Gmp_ing!

    Cheers,

    Ram B



    ------------------------------
    Ram Balani
    CEO-Founder
    eSTARHelper LLC www.estarhelper.com
    Amawalk, New York
    rbalani@estarhelper.com
    2019130558
    www.estarhelper.com
    ------------------------------

    Original Message


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