Wondfo Biotech Passes World Health Organization Pre-Accreditation Site Audit

On February 20, 2024, Wondfo Biotech received the letter of approval from the World Health Organization (WHO) for its pre-accreditation on-site inspection. Wondfo production process and quality management system were once again recognized by WHO. As one of the few IVD companies in China to have received WHO pre-certification, Wondfo has established a globally recognized international quality management system and continues to contribute China's strength to the construction of global health.

WHO Prequalification (PQ) is a certification system established by the United Nations in 2001 to ensure the quality, efficacy and safety of medicines procured by the International Fund for the benefit of patients in developing countries, and has become one of the most important standards in the international community to ensure the quality and safety of biomedical products, and an important threshold for procurement of medicines and in vitro diagnostic products by international organizations such as the World Health Organization, the United Nations Children's Fund (UNICEF) and the Global Fund. It has also become one of the important standards to ensure the quality and safety of biomedical products in the international community, and is an important threshold for the procurement of drugs and in vitro diagnostic products by international organizations such as the World Health Organization, the United Nations Children's Fund, the Global Fund and etc.
WHO has made detailed regulations on product safety and performance, design and manufacturing, and corporate quality management systems, etc. Only products that meet all the standards and pass the WHO laboratory assessment can eventually obtain WHO prequalification. As of November 23, 2023, only four Chinese IVD companies, including Wondfo Biotech, have passed the WHO PQ certification. Among them, two of Wondfo's products - HIV Test Pro and HIV Self-Test - have passed the WHO PQ certification, and the performance of the products and the company's quality management system have both gained international recognition. The performance of the products and the company's quality management system are both internationally recognized.

In October 2023, relevant WHO experts conducted an on-site cyclical re-audit of Wondfo Biotech, focusing on the implementation of WHO PQ and ISO 13485:2016 requirements in Wondfo manufacturing, warehousing, quality management and other aspects, and assessing Wondfo's ability to continuously maintain its WHO PQ qualification.
During the on-site review, the relevant WHO experts positively evaluated the quality management system and compliance management of Wondfo Biotech, and concluded that the documents and records provided by Wondfo clearly, completely and accurately reflected the product manufacturing process and quality management practices to ensure product quality and compliance.

The successful passage of the WHO on-site audit of Wondfo Biotech has once again verified that the manufacturing system and quality management system of Wondfo have stood the test and continue to meet the requirements of international certification. With the mission of "Racing for Life" on its shoulders, Wondfo insists on promoting high-quality development through scientific and technological innovation, actively participates in the construction of global health, and strives to realize the vision of "making biotechnology benefit the public".

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