GMP Management Of QC Lab

As a part of the quality management system, GMP management of QC lab is one of the important factors to ensure that the drug products are suitable for the intended use, comply with the drug standards and regulatory requirements. With the internationalization development, many domestic pharmaceutical enterprises must get the Chinese GMP certification, at the same time they maybe pass the FDA’s cGMP inspection, the PQ certification of the world health organization (WHO), EU’s CEP inspectionetc. In all kinds of audit inspection, QC lab inspection is the critical, the accuracy and authenticity of the data has become the biggest concern. There have many QC lab management problems in the FDA’s warning letters and 483 observations.This article from the Sino-US GMP inspection requirement of QC lab, analyzed the important contents about the GMP management of QC lab; from the actual situation of lab management in the domestic pharmaceutical enterprises, studied how to pass the GMP inspection at home and abroad. At present, in the process of implementation of GMP in China, from the concept and thought to understand the connotation of the GMP management of QC lab was not deep, the understanding of the importance and the purpose of GMP management of QC lab was not enough, and for reasons of cost can’t meet to the requirement of QC lab. Pharmaceutical enterprises want to go outside completely, must be in deep understanding of regulation requirements, according to own actual situation, improve the QC lab management. This article is intended to achieve the following goals:1.To master Sino-US laws and regulations for QC lab in the GMP management requirements; 2, Understand the common problem of QC lab in GMP inspection, and analyze the problem; 3,To master the critical control points for the GMP management of QC lab; 4, From the actual condition of pharmaceutical enterprises, to understand how to strengthen the GMP management of QC lab, to pass GMP inspection at home and abroad; Finally ensure the quality of product and protect the patient’s medication safety.