Artemether API: Guilin Pharma's first case to pass the WHO’s API-specific PQ certification
On 27th of May, Guilin Pharma's Artemether API received the PQ (product quality) certification by WHO, and became included in the WHO’s PQ certified API list for global buyers. As the 11th product from Guilin Pharma that has passed the WHO PQ certification through the many years’ efforts, the Artemether API is Guilin Pharma’s first PQ certified API in the history.
Guilin Pharma has been actively applying for the API-specific PQ certification since its initiation in October, 2010. (Before that, the PQ certification was only available for FPPs.) With no experience in passing the API-specific PQ certification though, after its long lasting deliberation and preparation, Guilin Pharma (the Shanghai Road site) ultimately delivered the first round PQ materials for the Artemether API in January, 2012. After relocation in July, 2012, the Artemether API product line API-II at the new Qilidian Road site passed the WHO GMP inspection; later in August, the acceptance number and the first round review comments were received. 42 questions were raised involving all aspects of physico-chemical property, process validation and impurity control; which challenged the company’s process control and research analysis. By its cross-functional efforts to meticulously collect, analyze and discuss a great deal of data, Guilin Pharma (the Qilidian Road site) submitted the first round response in November, 2013. The subsequent inspection schedule was then confirmed with WHO on May 16th, 2014. So far by leveraging only one round of response, Guilin Pharma’s Artemether API has successfully passed the PQ certification on May 27th, 2014.
This marks Guilin Pharma’s first case to have API-specific PQ certification by WHO, demonstrating (besides FPPs) the advanced international standard of the company’s APIs as the upstream in the production chain, and its first independent embarkment on WHO’s global sourcing platform. It sets the cornerstone for Guilin Pharma’s more APIs to go global; and the company will supply top-quality APIs for more global FPP manufacturers to further depict its grand blueprint toward internationalization.
Guilin Pharma has been actively applying for the API-specific PQ certification since its initiation in October, 2010. (Before that, the PQ certification was only available for FPPs.) With no experience in passing the API-specific PQ certification though, after its long lasting deliberation and preparation, Guilin Pharma (the Shanghai Road site) ultimately delivered the first round PQ materials for the Artemether API in January, 2012. After relocation in July, 2012, the Artemether API product line API-II at the new Qilidian Road site passed the WHO GMP inspection; later in August, the acceptance number and the first round review comments were received. 42 questions were raised involving all aspects of physico-chemical property, process validation and impurity control; which challenged the company’s process control and research analysis. By its cross-functional efforts to meticulously collect, analyze and discuss a great deal of data, Guilin Pharma (the Qilidian Road site) submitted the first round response in November, 2013. The subsequent inspection schedule was then confirmed with WHO on May 16th, 2014. So far by leveraging only one round of response, Guilin Pharma’s Artemether API has successfully passed the PQ certification on May 27th, 2014.
This marks Guilin Pharma’s first case to have API-specific PQ certification by WHO, demonstrating (besides FPPs) the advanced international standard of the company’s APIs as the upstream in the production chain, and its first independent embarkment on WHO’s global sourcing platform. It sets the cornerstone for Guilin Pharma’s more APIs to go global; and the company will supply top-quality APIs for more global FPP manufacturers to further depict its grand blueprint toward internationalization.