Standardized Management on Quality Control Equipment of Viral Vaccines Industry in China

Abstract

Aiming at the equipment used for quality control in the viral vaccine industry, this article sorts out the requirements for equipment management from three aspects: laws and regulations, industry quality management specifications and pharmacopoeia regulations. According to the characteristics of the vaccine industry and the principles and uses of commonly used equipment, the instruments and equipment used for quality control are divided into five categories, and the management characteristics of these categories are explained. It is recommended to refer to the United States Pharmacopoeia and the characteristics of my country's vaccine industry to adopt a 4Q management model for the management of quality evaluation equipment, that is, equipment design qualification (DQ), installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ). Standardized management of equipment is an important guarantee for the accuracy and traceability of quality control of viral products.