On the quality stability management of pharmaceutical package based on Cybernetics

Requirements for quality stability of package materials

The first chapter of chapter third of the "standard for the management of drug quality and production (revised in 2010)" stipulates that "this standard is the quality management of the standard."

Part of the system is the basic requirement of drug production management and quality control, and it is aimed at... Ensure sustained and stable production of drugs that meet the intended use and registration requirements. "

The second chapter, the sixth rule, "enterprise top management should ensure the achievement of the established quality goals. People of different levels, suppliers and distributors should participate in and undertake their respective responsibilities."

In fact, the continuous and stable drug quality is the requirement for the quality of the drug production and the quality of the packaging material for the direct contact with the drug. This is because the quality of medicines depends on many factors, such as production technology, raw materials, packaging materials, production equipment and production environment. Among them, packaging materials directly contacting drugs are important factors. Moreover, in the "drug quality production management standard (2010 Revision)", the requirements for the management and control of the packaging materials for direct contact with drugs are the same as those of raw and auxiliary materials. In order to achieve this requirement, the pharmaceutical enterprises must decompose the responsibility, in which the quality responsibility of the pharmaceutical package is mainly undertaken by the pharmaceutical package enterprises.