Report: Quality Control and Assurance Lapses Most Frequent Issues Among Chinese Drugmakers

June 15, 2016

Quality control and assurance issues were found to be the most common deficiency in 2015 among drugmakers inspected in China, a report says.

According to a report issued by the China Food and Drug Administration, 609 — or 20 percent — of the 3,045 deficiencies discovered from inspections were related to quality control and assurance.

Typical examples of QC deficiencies included failure to validate a sterility test method for rubber stoppers; failure to record expiration dates of reagents; and poor handling of deviations, which were often not handled in a timely manner.

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