ISPE QC/Analytical Community of Practice Established
ISPE
JUNE 2, 2023
reduce non-value-added tests) Contract lab management Reference standards & critical reagent management Rapid micro testing Training (e.g.,
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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
The FDA Law Blog
FEBRUARY 13, 2025
The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). Details of the PCCP will be publicly available (i.e.,
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