More Trouble for Chinese Drug Manufacturing

Yet again China's drug industry is having manufacturing issues.

The U.S. Food and Drug Administration (FDA) added Zhejiang Hisoar Pharmaceutical to its import alert list due to violations discovered at its Taizhou City plant. The company was banned from sending all antibiotics and drugs for humans or animals that were manufactured at that plant to the United States.

The import alert stems from an inspection of the facility in August 2015, during which FDA personnel discovered data integrity issues, namely that quality records had been deleted and test records had been altered, with failing results sometimes going unreported.

Hisoar, which has manufactured ingredients for Pfizer, Novartis, and Sanofi, is among the more than 40 Chinese drug manufacturing plants that are banned from sending their products to the United States.

The FDA has yet to determine how long this ban will be in effect. The agency won’t lift the ban until it has received sufficient evidence that the products are safe and that “future shipments will be in compliance with the law,” according to a statement on the FDA’s consumer page on its website.

This action marks just one of several ongoing issues surrounding drug and ingredient manufacturers in China. The companies in question are facing increased FDA and European Medicines Agency (EMA) scrutiny.

Metronidazole

The EMA posted an action against Hubei Hongyuan Pharmaceutical after discovering the unacceptable conditions of its Huanggany City plant. The company, which manufactures the popular antibiotic metronidazole, informed the EMA that that plant “does not follow EU GMP [good manufacturing practice].”

In addition, the following critical observations were made:

a. The manufacturing site and its equipment was found in a devastated state.

b. Huge layers of dust and product indicated that no cleaning was applied to either the facility or the equipment, leading to an extreme risk of cross-contamination.

c. The extremely bad shape of the facility and the equipment showed that no maintenance was in place.

d. Almost none of the products seen was labelled.

e. No batch manufacturing documentation could be seen.

Another EMA report on the same plant noted that inspectors identified “24 deficiencies to EU GMP”while examining metronidazole production, one of which was labeled as “critical” and 10 of which were labeled as “major.” The critical deficiency had to do with the company’s Quality Assurance System for the production of metronidazole, and the major deficiencies were “related to: QA, Documentation, Supplier Qualification, Data Integrity, Out-of-Specification handling, Quality Control, Computerised System validation, Change Control.”

-Meredith Edwards White

References:

1. U.S. Food and Drug Administration. Import alert 66-40. www.fda.gov. Accessed February 4, 2016.

2. Edney A. Chinese pharmaceutical firm Hisoar added to U.S. import ban. BloombergBusiness. www.bloomberg.com. 2016 Jan 20.

3. U.S. Food and Drug Administration. Import alerts guard against unsafe products. www.fda.gov. Accessed February 4, 2016.