News about GMP/cGMP


CFDA: 2016 Report on Drug Inspections

The China Food and Drug Administration (CFDA) released a detailed report on inspections conducted throughout the last year. A total of 431 inspections including pre-approval inspections, GMP certification inspections, GMP follow-up inspections, unannounced inspections, overseas inspections, GSP unannounced inspection and inspection observations are analysed therein.

As might have been expected two hotspots were identified as common findings: Missing data integrity and consistency of production processes. The problems listed range from missing retain samples, missing laboratory results, missing stability testings up to unsolved deviation problems.

Part V of the Annual Report deals with overseas inspections. Here are some numbers:

  • Originally, an overall of 49 inspections was planned to be conducted in 19 countries. 33 in Europe, six in Northern America, two in Southern America, six in Southeast Asia, one in India and one in Australia.
  • Finally, only seven of the 49 pharmaceutical manufacturers were inspected by the end of 2016.
  • 21 inspections were postponed, as the sites “could not accept an inspection” earlier than late 2017.
  • Eight foreign manufacturers proactively withdrew the import registration certificate during the organization of the inspection.
  • Three manufacturing sites were categorized to be insufficient.
  • An overall of three critical deviations and 18 major findings were detected. The problems mainly focused on Quality Control and Quality Assurance, Material System and Change Management and again on Data Integrity.

Click here to get to the Annual Report of the CFDA.


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