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    Tag: Regulatory News

    Working document QAS/16.671: GUIDELINES ON VALIDATION - APPENDIX 4: ANALYTICAL METHOD VALIDATION
    Blog: Site News | Posted By: Denyse Baker | Released: June 28, 2016, 11:32 am

    WHO released the latest in their series of draft guidelines related to validation today. PDA is soliciting volunteers to help develop a response to this draft appendix 4 on Analytical Method Validation. Please contact Denyse Baker (baker@pda.org) if you are interested and available to participate.

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    Announcements | Analytical Methods | Regulatory News | Validation

    FDA Final Guidance on Elemental Impurities - ICH Q3D - is adopted.
    Blog: Site News | Posted By: Janeen Skutnik-Wilkinson | Released: September 10, 2015, 5:33 am

    FDA Finalizes ICH Q3D guidance establishing permitted daily exposures for 24 elements in drug products based on evaluation of tox data.

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    Announcements | Regulatory News