Recently, the World Health Organization (WHO) carried out a pre-certification on-site inspection on an in vitro diagnostic reagent production enterprises of human immunodeficiency virus (HIV1/2) antibody detection reagent (latex method), hepatitis C virus antibody test kit (colloidal gold method), hepatitis B virus surface antigen detection reagent (colloidal gold method) and other 3 products in Hangzhou, Zhejiang. It’s the first time that WHO does pre-certification test for in vitro diagnostic reagents production enterprises in Zhejiang province and Zhejiang provincial drug certification inspection center sent observers to observe.
In the 3 days of pre-certification inspection, Sabine Ohse and other 3 WHO certification experts audit the quality management system, production, verification and other documents, field view of the production workshop, water equipment and warehouse according to ISO13485 requirements. They also asked about affairs on product design development, production, sales, transportation, customer storage, use and other aspects of the relevant problems.
In this pre-certification, WHO expert group takes product safety as the guideline and carry out reviews and pays more attention on the quality of enterprise production system management details. In the inspecion process, WHO expert group agrees on the enterprise’s preparation and testing of processing water, and the management of hazardous chemicals. Also they put forward more proposals on the problems of the product transportation stability test, the stability test of buffer solution, the product risk management and the training of the dealers.