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