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ICH Expands on Analytical Methods Validation in Draft – Q2 Update

September 22, 2022
The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.
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Juan Hinojosa, Quality EngineerClearCam
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Enhao Gong, CEOSubtle Medical
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