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Series of manufacturing disasters highlights importance of partner due diligence in China
Chinese CMOs with a proven track record in quality will be able to differentiate themselves amidst the series of manufacturing problems this year, and the ongoing US-China trade war, says GlobalData

The recent pharma regulatory reforms by China are expected to provide opportunities for both domestic as well as foreign contract manufacturing organisations (CMOs).

A series of recent manufacturing scandals highlights the importance of performing due diligence when picking a pharma manufacturing partner in the country, says data and analytics company GlobalData.

In July, the European Medicines Agency discovered N-nitrosodimethylamine, a probable carcinogen, in batches of the drug valsartan, which is used to treat high blood pressure and heart failure, manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.

The problem was much larger than originally thought as soon after, the same contaminant was discovered in valsartan made by another CMO, Zhejiang Tianyu Pharmaceutical Co Ltd. Regulators then found a second impurity, N-Nitrosodiethylamine, in many valsartan batches.

Fiona Barry, associate editor of GlobalData’s PharmSource said, “Unlike many of the other manufacturing problems in China this summer, the CMOs involved in the valsartan production did little wrong. The impurity arose because of changes in the way the active substance was manufactured, but these changes had been approved by regulators which also missed the problem.”

Since the discovery of the problem, regulators have developed two methods to detect the impurities in valsartan drug products—a chromatography-tandem mass spectrometry (GC-MS/MS) method utilising liquid injection and a combined gas chromatography-mass spectrometry (GC/MS) headspace method.

Separate scandals have also hit other Chinese pharma manufacturers. Most recently, Changchun Changsheng Life Sciences Ltd. was fined following an investigation into its illegal production of human rabies vaccine. The controversy and spot checks prompted by the Changsheng scandal have caught out other Chinese pharma manufacturers.

Anonymous whistle-blowers claiming to be employees of Chongqing Pharmaceutical Research Institute, a generic API and development services subsidiary of Shanghai Fosun Pharmaceutical Group Co. Ltd., accused the company of using unapproved processes and using fraudulent records to apply for GMP certification of a new production facility in Chongqing’s Changshou district.

With its reputation at stake, China has been attempting to overhaul its regulatory process with a series of rapid policy changes. In September 2018, China restructured its medicines regulator from China Food and Drug Administration (CFDA) to National Medical Products Administration (NMPA).

Barry concludes: “The manufacturing problems experienced this year, and the ongoing US-China trade war means China requires careful consideration as a partner. Chinese CMOs with a proven track record in quality and in partnering with foreign companies, or even with their own footprint in the US or EU, will be able to differentiate themselves.”

Source: GlobalData

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