Tag: US FDA guidelines on Quality audits

USFDA Guidelines quality audits 21 CFR Sec.820.22 Medical devises

USFDA in its guidelines on Quality System, it has mentioned guidelines regulations, means it’s mandatory for pharmaceutical manufacturing units to follow the Guidelines. US FDA guidelines on Quality audits mention that Pharma Manufacturer must have a Procedure for quality audits, these must ensure and establish that Quality systems are followed and are in state of […]

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