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  • 1.  Benchmarking Topic: Acceptance Criteria in Regulatory Protocols

    Community Leadership
    Posted 08-06-2023 23:29

    Does your company put acceptance criteria in the following sections:

    1. 3.2.S.7.1 and 3.2.P.8.1  (stability protocols)
    2. 3.2.S.7.2 and 3.2.P.8.2  (post approval protocols)

    Respond here, this question will also be discussed in the August Stability Community Meeting.



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    Lori McCaig
    Director Global Stability Program Management
    Seagen, Inc.
    San Jose CA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Benchmarking Topic: Acceptance Criteria in Regulatory Protocols

    Posted 08-11-2023 11:01

    Answer is NO for all these sections, based on my experience at Merck (small molecules 1998-2012), J&J Consumer (now Kenvue - Self-Care/OTC 2012-2022) and GSK (biopharm/large molecules 2022 to present).

    A reference to the shelf-life specifications or acceptance criteria in the corresponding 3.2.S.4.1 and 3.2.P.5.1 sections should suffice.

    The only exceptions included in the 3.2.P.8.1 and 3.2.S.7.1 are acceptance criteria for any additional non-registered internal tests or any criteria applicable to clinical materials that do not apply to commercial material.



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    Jing Capucao
    Stability Manager
    GSK
    Conshohocken PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message


  • 3.  RE: Benchmarking Topic: Acceptance Criteria in Regulatory Protocols

    Posted 08-14-2023 12:44

    3.2.S.7.1 and 3.2.P.8.1 (stability protocols):

    Answer:  Bios (up to 2023):  Yes; Bios (2023):  No; Vaccines:  Yes

    3.2.S.7.2 and 3.2.P.8.2  (post approval protocols)

    Answer:  Bios (up to 2023):  Yes; Bios (2023):  No; Vaccines:  Yes

    .......................................................................................................

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer



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    Robert Dufield
    A.R. Fellow Scientist; Stability Group Leader
    Pfizer Global R&D
    Overland Park KS
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message


  • 4.  RE: Benchmarking Topic: Acceptance Criteria in Regulatory Protocols

    Community Leadership
    Posted 08-15-2023 17:08

    Similar to Jing, we make a reference to S.4.1 or P.5.1 sections.  This helps us from having to update multiple documents if the specifications change



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    Kayla Woodlief B.S.
    Director
    Vir Biotechnology
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message