Manufacturing certifications reveal the quality of a manufacturer’s operation. This includes the quality of the facility, the organization of its operations, adherence to important procedural steps, the control of quality and safety and how it is implemented and recorded. Each country may have its own standard of excellence and certification. A mark of a globalized facility is often distinguished in the various certifications they acquire from those regions that strictly enforce high standards of quality and safety.
In 2015, SUN TEN Laboratories received NSF International certification, the public health and safety organization, as a GMP compliant Dietary Supplement manufacturing facility. In 2010, SUN TEN Laboratories received certification through the National Products Association (NPA) as a GMP compliant Dietary Supplement manufacturing facility.
In 1992, SUN TEN became the first Chinese herbal extract manufacturer in Taiwan to obtain GMP certification from the Australia Therapeutic Goods Administration (TGA). SUN TEN is the only Chinese herbal extract manufacturer in Taiwan to receive PIC/s GMP certification from Australia TGA, in 2004, 2006 and 2009.
In 1975, SUN TEN began export to Japan. SUN TEN is the first TCM manufacturer in Taiwan to qualify for the reimbursable prescription by Japanese Health Insurance Plan. SUN TEN is the first Chinese herbal extract manufacturer in Taiwan to receive Japan’s new GMP accreditation of foreign manufacture site in 2007.
In 1996, SUN TEN products were approved with import drug license by the Drug Control Administration (DCA) in Malaysia.
SUN TEN is among the first group of Chinese herbal extract manufacturer in Taiwan to receive Taiwan GMP certification in 1988.
SUN TEN received ISO 9001 certification from UK British Standard Institution in 1992.
Good Manufacturing Practices (GMP) are guidelines that outline the aspects of production and testing that can impact the quality of a product. GMP encompass the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods and dietary supplements, pharmaceutical products, and medical devices. Many countries have legislated GMP procedures and regulations that pharmaceutical and medical device companies must follow.
The Therapeutic Goods Administration (TGA) carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as “complementary medicines”. These are regulated as medicines under the Therapeutics Goods Act 1989. Complementary medicines comprise of traditional medicines, including traditional Chinese medicines, Ayurvedic medicines and Australian indigenous medicines. All products exported to Australia require TGA listing for which the TGA GMP Certificate is a prerequisite.
PIC/S refers to joint international pharmaceutical inspection authorities: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme which together provide co-operation in the field of GMP.
PIC/S’ mission is “to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medinceinal products.”
PIC/S establishes cohesive GMP standards, guidance documents, training, and inspection. Cohesive international collaboration of PIC/S facilities promotes GMP standards that are internationally verified by strict approval yet harmonious in global commerce.
Australia’s TGA is a participating authority in PIC/S, therefore, TGA GMP inspection is based on PIC/S GMP guidance.
In 2001, SUN TEN co-developed a cancer adjuvant with PhytoCeutica Inc. for cancer therapy and filed a botanical drug IND (Investigational New Drug) with US FDA.
SUN TEN has also manufactured a herbal formula for Phytopharm PLC (UK) to conduct clinical trials in Europe. The formula is currently marketed as an herbal supplement to treat skin disorders in dogs.
SUN TEN manufactures for and exports to many foreign markets. We must maintain necessary certifications and be compliant to specific specifications mandated by each governmental policy to ensure product safety and quality.