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Domestic Pharma Manufacturing Site Inspections significantly decline for CFDA

According to a recently released annual report from the Center for Food and Drug Inspection of CFDA (China’s Food and Drug Administration), CFDA inspected less than half the number of pharmaceutical manufacturers in 2015 as compared with 2014.

In the year 2015, CFDA conducted 221 inspections for pharmaceutical good manufacturing practice (GMP) certification, out of which 212 passed and 9 (4%) failed, and 68 enterprises received warning letters. CFDA conducted 584 GMP inspections in 2013 (and issued 104 warning letters) and in 2014, conducted 482 inspections and sent 146 warning letters. The report claims that as the number of domestic inspections has decreased significantly “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the ratio of rectification inspection reaching 13%.”

According to the agency’s statistical analysis, the most deficiencies cited in warning letters were linked to quality control and assurance, documentation management, staff training, equipment and qualification and verification.


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