Regulatory Focus™ > News Articles > CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

Posted 08 June 2016 | By Zachary Brennan 

CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

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

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%.”

The Chinese regulator said it’s increasingly finding critical deficiencies with data integrity, including data manipulation, and untraceability of data and production behavior.

By the Numbers

For 2015, CFDA conducted 221 inspections for pharmaceutical good manufacturing practice (GMP) certification, of which 212 passed and 9 (4%) failed, while 68 enterprises received warning letters.

By comparison, CFDA conducted 584 GMP inspections in 2013 (and issued 104 warning letters) and in 2014, conducted 482 inspections and sent 146 warning letters.

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

Staff training was also a major issue for companies, as the most frequently cited deficiency clause was: “All personnel related to pharmaceutical production and quality shall be provided with relevant training, of which the content shall meet the requirements of the post.”

Center for Food and Drug Inspection of CFDA Annual Report on Drug Inspection (2015)


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