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並前往https://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

Data Integrity and Compliance With CGMP Guidance for Industry

accurate (ALCOA). 4. 75. 2 FDA's authority for CGMP comes from FD&C Act section 501(a)(2)(B), which states that a drug shall be deemed.

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