SGS opens new micro test lab in China
The 700 square metre laboratory, which employs 27 full time analytical staff, will offer local drug developers current good manufacturing (cGMP) practice standard microbiology, stability and endotoxin assessment services for active pharmaceutical ingredients (API), finished products and traditional Chinese medicines.
The quality of APIs and drugs from China has become an increasing concern for patients and importers worldwide following a series of high profile contamination problems that emerged in recent year.
While standards in China are beginning to improve as a result of efforts by both the Chinese Food and Drug Administration (SFDA) and other regulators, analytical testing capacity has not grown at the same rate as the manufacturing sector, creating demand for contract offerings like SGS’.
Ulrich Markens, vice president and regional manager of SGS’ Chinese operations, explained that the firm had “received [an increasing number of] requests from several multinational companies for microbiology testing in a fully cGMP-compliant environment.”
Markens added that: “Integrating microbiological testing broadens our service portfolio…in compliance with the increased scrutiny of pharmaceutical manufacturing in China by the US Food and Drug Administration (FDA).”
The laboratory, which began offering contract analytical services in January 2006, is part of SGS’ integrated network of 14 cGMP-compliant testing facilities worldwide that the firm believes enhances the quality control operations of both its local and multinational pharmaceutical industry clients.
SGS also said that the laboratory, which already holds a Chinese National Accreditation Board for Laboratories’ ISO 17025 certification, further expands its range of offerings in the country.
The firm offers consultancy in regulatory affairs and the registration of medical products in both Hong Kong and China, third party facility inspection and auditing services and advises producers of import and export requirements.
