New GMP and new concepts

The new version of GMP introduces the new concept of quality risk management in time, such as explicitly requiring enterprises to establish a quality management system, introducing risk management into quality management, and emphasizing that the implementation of GMP should be based on science and risk.

There are risks such as pollution, cross-contamination, confusion and errors in the pharmaceutical production process, so we can't simply find the problems through inspection according to the quality standards, and we must control them in the production process. Therefore, the concept of risk management has been introduced into the new GMP, and a series of new systems have been added accordingly, such as supplier audit and approval, change control, deviation management, OOS investigation, corrective and preventive measures (CAPA), continuous stability inspection plan, and product quality traceability analysis. , from the procurement of raw and auxiliary materials, production process changes, deviation handling in operation, investigation and correction of found problems, drug quality after listing, etc. Manage and control the risks that may occur in each link, so as to urge the production enterprises to establish the whole chain and corresponding systems, discover the unsafe factors that affect the quality of drugs in time, actively prevent the occurrence of quality accidents, and ensure the quality of finished products and listed drugs to the maximum extent.

Secondly, the new concept of quality management system is introduced. The new GMP clearly requires pharmaceutical enterprises to establish a comprehensive, systematic and strict quality management system, and must be equipped with sufficient resources, including human resources and management systems, to ensure the effective operation of the quality system.

In the past, in the minds of many people, quality management and GMP implementation were the business of quality management departments and quality management personnel. The new version of GMP embodies the concept of full participation in quality, emphasizing the quality responsibility of legal persons and business leaders, including quality leaders and quality authorizers, which makes the quality management of pharmaceutical production enterprises more comprehensive and in-depth. This is the further implementation of "enterprise is the first person responsible for drug quality", which embodies the modern enterprise management concept of institutionalized management.