The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China.

FDA issues Warning Letter for API Facility

http://www.gmp-compliance.org/enews_4367_FDA%20issues%20Warning%20Letter%20for%20API%20Facility_8509,S-WKS_n.html
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.

FDA issues Warning Letter for API Facility
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility.

For quite some time India was in the center of attention and very little was heard about GMP problems in China (see also RAPS article). This is a bit surprising because a number of non-compliant facilities have been detected in the past. Also the facilities which caused the Heparin Scandal were located in China. The last enforcement action from FDA which became public referred to Import Alerts for the manufacturer Zhejiang Jiuzhou Pharmaceutical and for Zhejiang Zonebanne in China.

The new Warning Letter for Tianjin Zhongan Pharmaceutical lists a number of different non compliance findings. These findings refer to equipment cleaning (risk of cross contamination), not adequate Change Control procedures and failure to adequately review and investigate product deviations. However, in difference to the Warning Letters sent to Indian manufacturers recently data integrity issues have not been detected.

Interestingly the API manufacturer Tianjin Zhongan Pharmaceutical is not listed in EudraGMDP the inspection database in the EU. No entry for GMP Certificates or GMP Non-Compliance Report are available.

Source: FDA Warning Letter to Tianjin Zhongan Pharmaceutical

Tianjin Zhong’an Pharmaceutical Company Ltd. locates in the southwest of Tianjin. Set up in 1988, the company underwent operation mechanism reform in 2002 and acquired the present name.

The company covers an area of 82,000 square meters, with a construction area of 31,600 square meters and an afforested area of 13,300 square meters. It has over 600 staff members, more than 50 of whom have been conferred intermediate or advanced titles of technical post. The company produces 10 major chemical bulk pharmaceuticals, including Caffeine, Theophylline, Aminophylline, Metronidazole, Metronidazole Benzoate, Nifedipine, Secnidazole and Xanthinol Nicotinate. Its annual production capacity amounts to 4000 ton, with a sales volume of approximately RMB 250 million. Two leading products in the company are Caffeine and Metronidazole.

Zhong’an Pharmaceutical enjoys a self-management power over import and export., 90% of its products are aimed at international market, with 60% of which sold directly to world-renowned pharmaceutical and beverage enterprises. It has established a sales network which covers more than 30 countries and regions, including some European and American countries, Hong Kong, Taiwan and Macao, countries in Southeast and Midwest Asia, and Russia.

Zhong’an Pharmaceutical has set up a full set of quality assurance system, and owns a central laboratory with advanced analyse instruments that has got the title of Export Enterprise Lab and approved by Tianjin entry-exit inspection and quarantine bureau. All workshops of the company are dedicated to avoid the issue of cross pollution. Every stage of production strict complies with the cGMP, which led to the products has been enjoying a high reputation both domestic and overseas market.

Since 2000, the company has obtained GMP and ISO9001certificates, and conferred the title of Tianjin High-new Tech Enterprise and Municipal-level Key Technical Center. Both of leading products Metronidazole and Caffeine have got COS issued by EDQM and DMF register number from US FDA. Also Caffeine has got “Foreign Manufacturer Validation Certificate” from Japan Health Ministry and KOF-K and Halal certificates.