Equipped with instruments ranging from GC/MS to LC/MS/MS, the laboratory will provide services for method development and validation, stability studies, testing of raw materials, active pharmaceutical ingredient (API) and finished products, as well as testing of traditional chinese medicines.
SGS has several offices and laboratories in China with more than 4,000 employees, but the new laboratory if the first for pharma QC in the country and expands the Swiss company's network of 16 pharmaceutical QC operations in North America, Europe and Asia.
Driving the demand for pharma QC testing are foreign buyers requesting testing of materials they want to buy in China and domestic firms wishing to use an internationally recognised lab to test their products for export into Western markets
Moreover, Chinese companies engaged in drug development often lack the sophisticated equipment in QC, choosing to focus on core manufacturing activities and outsource analytical tasks.
"SGS uses state-of-the-art equipment, you will hardly find in Chinese pharma companies, to fullfil the most demanding requests of its customers," Manfred Weiler, SGS's global business manager for QC testing, told In-PharmaTechnologist.com.
"Standard QC testing - batch release of finished product - is not allowed under current Chinese drug law so companies outsource analytical testing such as stability studies, impurity testing and method development and validation."
SGS will also provide inspection and good manufacturing practice (GMP) gap auditing services, a special demand from western companies sourcing raw materials and API in China.
In addition, SGS offers consultancy on regulatory issues with regard to registration of medical products in China and Hong Kong as well as export and import related requirements.
Chinese companies are eager to learn how to sell their product into foreign markets and SGS has the necessary regulatory expertise not only in Chinese GMP but also in foreign regulatory requirements, such as of the US Food and Drug Administration (FDA), European Medicines Agency (EMEA) and Health Canada.
The laboratory which was constructed with an initial investment of RMB6m (€600,000) and has been in operation since January, received ISO 17025 accreditation from the CNAL (Chinese National Accreditation for Laboratory) in May.