Surprise pharma inspections uncover 50% failure rate

Chanice Henry

The China Food and Drug Administration (CFDA) conducted over 430 pharma inspections last year, which saw over 50% of the drug manufacturers disappoint expectations 

Around 39 unannounced inspections took place in 2016 and 54% of the drug manufacturers involved failed. It was considered whether GMP certificates should be repealed for around 14 of those firms.

Flawed products that belonged to seven firms were ordered for recall. All issues have been rectified in accordance with legislation

The CFDA achieved a five year high for overseas inspections for imported pharmaceuticals. The 49 inspections stretched across 19 countries.

Issues with data integrity had serious repercussions on medicine integrity with some manufacturers.

All issues have now been dealt with, quality control and quality assurance were found to be the dominant problem areas. The production processes used in manufacturing plants were in some instances found to differ from those specified in registration application, major changes had been made without an application.

Ding Jianhua, Director of Department of Drug and Cosmetics Supervision of the CFDA says, "One manufacturer from a European Union country didn't report to the CFDA their major change and even added some APIs, active ingredients to their production, they didn't report their source of materials, we stopped the importation of them.”

He added that foreign manufacturers did follow Chinese regulations, however some smaller companies in developing countries sometimes were not aware of Chinese regulations or forgot about the region’s  requirements.

Around 12 pharma manufacturers passed their GMP certification inspections, of the seven that struggled to pass their certification, issues were again primarily linked to quality control, quality assurance, documentation management followed by equipment deficiencies.  

Quality management systems were a key stumbling point – not operating effectively and failing to meet production and quality requirements for products. The operability of the files was lacking and data wasn’t recorded in some instances.

For some firms inspected process validation was not adequate for all medicines including the cleaning validation for public equipment.

The audits ran by the CFDA included: pre-approval inspections, GMP certification inspections, GMP follow-up inspections, unannounced inspections, overseas inspections, GSP unannounced inspections and inspection observations. These involved around 1270 inspectors.