Based on control theory, on the quality of pharmaceutical packaging stability management

Requirements for packaging quality stability

"Specification for production management of drug quality (2010 Revision)" the first chapter the provisions of article third, "this specification as a quality management

A part of the system, is the basic requirement of drug production management and quality control, to...... To ensure the continuous and stable production to meet the intended use of the drug and registration requirements."

The second chapter sixth provisions, "senior management enterprise shall ensure the achievement of the quality objectives established, different levels of staff and suppliers, dealers should participate in and bear their respective responsibilities."

In fact, continuous and stable quality of drugs is on the quality of pharmaceutical production requirements, but also on the direct contact with the drug packaging materials production quality requirements. This is because many factors of drug quality depends on the production process, raw and auxiliary materials, packaging materials, production equipment, production environment, including drug packaging materials is one of the important factors. Moreover, in the "standardized production management of drug quality (2010 Revision)", on the immediate packaging materials management and control requirements have been as raw material is.

In order to achieve this requirement, pharmaceutical enterprises must carry on decomposition of responsibility, the responsibility for the quality of packaging is mainly the responsibility of packaging enterprises.

"Specification for production management of drug quality (2010 Revision)" issued, the State Food and drug administration has issued a circular: since March 1, 2011 onwards, where a new drug production enterprises, pharmaceutical production enterprises to build (change, extend) workshop shall be in compliance with the "drug quality students standard production management (2010 Revision)" requirements. Existing drugs production enterprise of blood products, vaccines, injection of sterile drug production, in 2013 before 31 December to "standardize production management of drug quality (2010 Revision)" requirements. Other classes of drugs production should be in 2015 December 31 before reaching the "standardized production management of drug quality (2010 Revision)" requirements.

In the face of a lot of the requirements of the national pharmaceutical production enterprise to put forward, packaging enterprises as the main supplier of pharmaceutical production enterprises, we must fully recognize the importance and urgency of packaging to stability of quality management, and to take timely measures to meet this requirement.

The packaging enterprises generally smaller scale, the academic research on packaging quality management is not perfect, only limited to

Meet the State Food and Drug Administration thirteenth orders review requirements, in order to achieve registration certificate, and then through the GB/T19001 quality system certification, that reach the quality stability requirements. In fact, if not on the packaging quality stability management in accordance with the scientific management methods, the frequency of occurrence of packaging quality defect is very high, so it can only rely on the price advantage to seize the market, bring greater risks to the stability of drug quality.