Global Certifications: GMP, TGA, and PIC/S
Global Certifications: A Testament to Sun Ten's Credibility and Quality
Manufacturing certifications reveal the quality of the facility, organization of operations, adherence to important procedural steps, and control over quality and safety and how they are implemented and recorded. Sun Ten has received GMP, TGA, and PIC/S certifications.
United States–SUN TEN Laboratories
In 2010, SUN TEN Laboratories received certification through the National Products Association (NPA) as a GMP compliant dietary supplement manufacturing facility. In 2015, SUN TEN Laboratories received the Public Health and Safety Organization’s NSF International Certification.
In 1992, SUN TEN became the first Chinese herbal extraction manufacturer from Taiwan to obtain GMP certification from the Australia Therapeutic Goods Administration (TGA). SUN TEN is the only Chinese herbal extract manufacturer from Taiwan to receive PIC/S GMP certification from Australia’s TGA, in 2004, 2006 and 2009.
In 1975, SUN TEN began exporting to Japan. SUN TEN is the first TCM manufacturer from Taiwan to qualify for reimbursable prescription by the Japanese Health Insurance Plan. SUN TEN is also the first Chinese herbal extraction manufacturer from Taiwan to be an Accredited Foreign Manufacturer in Japan.
In 1996, SUN TEN products were approved for an Import Drug License by the Drug Control Administration (DCA) in Malaysia.
SUN TEN was among the first Chinese herbal extraction manufacturers in Taiwan to receive Taiwan’s GMP certification in 1988.
Understanding Sun Ten's Certifications: GMP, TGA, and PIC/S
Good Manufacturing Practices (GMP):
Good Manufacturing Processes (GMP) are guidelines that outline the aspects of production and testing that create a quality 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.
Therapeutic Goods Administration (TGA):
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 Therapeutic Goods Act of 1989. Complementary medicines are comprised of traditional medicines, including traditional Chinese medicines, Ayurvedic medicines and indigenous Australian medicines. All TCM products exported to Australia require TGA listing for which the TGA GMP Certificate is a prerequisite.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S):
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 standards and quality systems of inspectorates in the field of medicinal 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 are 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.