Yaopharma successfully passed the WHO pre-qualification (WHO PQ) on-site inspection

18 / 06 / 2024

Yaopharma received the WHO pre-qualification (WHO PQ) on-site inspection approval letter recently, confirming that Yaopharma's oral solid production line I and its associated API production line GMP system meet the WHO GMP requirements.

During the on-site inspection, the WHO inspectors gave positive comments on Yaopharma's production and quality management system, believing that the documents and records provided by Yaopharma clearly, completely and accurately reflected the product production process and quality management practices, ensuring product quality and regulatory compliance.

Yaopharma's finished product successfully passing the WHO PQ on-site inspection represents another international recognition after Health Canada and US FDA GMP certification. It signifies that Yaopharma products not only gain access to the European and American markets but also open doors to many more developing countries, allowing more and more global patients to benefit from high-quality medicines and services from China, and contributing Chinese strength to the global health cause.

It is reported that the solid dosage production line that passed inspection this time also produces several of Yaopharma's star products including Atuomolan, Kailaizhi, and Liqing under the same quality management system.

The WHO Prequalification (WHO PQ) is a certification system established by the United Nations in 2001 to ensure the quality, efficacy and safety of medicines purchased by international funds and to serve patients in developing countries. It has now become one of the important standards for the international community to ensure the quality and safety of biopharmaceutical products. It is also an important threshold for international organizations such as the World Health Organization, the United Nations Children's Fund, and the Global Fund to purchase medicines and in vitro diagnostic products.