Analysis of the FDA Drug GMP Inspection Observations from Fiscal Year 2019 to 2023
Objective To improve the quality management level of pharmaceutical production in enterprises.Methods Statistical analysis was conducted on the form 483 inspection observations under the drug category released by the US Food and Drug Administration(FDA)from fiscal year 2019 to 2023.The data were analyzed by the cite ids,citation clause number and Good Manufacturing Practice(GMP)chapters respectively,and corresponding insights were summarized.Results Combined cite ids and citation clause numbers,FDA found more deficiencies in quality management,deviation management,written records and process control procedures,laboratory and microbial control.Conclusion Enterprises should establish a quality management system for the entire life cycle of drugs and operating procedures for handling deviations.Drug regulatory agencies should strengthen drug supervision through information technology.
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