Based on control theory, discussing the quality and stability management of health products
07 May,2025
Stability Requirements for Health Product Materials
Article 3 of Chapter 1 of the "Good Manufacturing Practice for Drugs (2010 Revision)" stipulates that "As part of the quality management system, this specification is the basic requirement for drug production management and quality control, aiming to... ensure the continuous and stable production of drugs that meet their intended purpose and registration requirements." Article 6 of Chapter 2 stipulates that "Senior management personnel of the enterprise should ensure the achievement of predetermined quality objectives, and personnel at different levels, as well as suppliers and distributors, should jointly participate and assume their respective responsibilities." In fact, the continuous stability of drug quality is a requirement for drug production quality, but also a requirement for the production quality of packaging materials that directly contact drugs. This is because drug quality depends on various factors such as production processes, raw and auxiliary materials, packaging materials, production equipment, and production environment, among which packaging materials that directly contact drugs are one of the important factors. Moreover, in the "Good Manufacturing Practice for Drugs (2010 Revision)", the management and control requirements for packaging materials that directly contact drugs are the same as those for raw and auxiliary materials. In order to achieve this requirement, pharmaceutical enterprises must decompose responsibilities, and the quality responsibility of health product materials is mainly borne by health product material enterprises.
On the date of the release of the "Good Manufacturing Practice for Drugs (2010 Revision)", the State Food and Drug Administration issued a notice: From March 1, 2011, all newly established pharmaceutical production enterprises and newly established (reconstructed, expanded) workshops of pharmaceutical production enterprises must meet the requirements of the "Good Manufacturing Practice for Drugs (2010 Revision)". The production of aseptic drugs such as blood products, vaccines, and injections in existing pharmaceutical production enterprises should meet the requirements of the "Good Manufacturing Practice for Drugs (2010 Revision)" by December 31, 2013. The production of other categories of drugs should meet the requirements of the "Good Manufacturing Practice for Drugs (2010 Revision)" by December 31, 2015.
Faced with the many requirements put forward by the state for pharmaceutical production enterprises, health product material enterprises, as the main suppliers of pharmaceutical production enterprises, must fully recognize the importance and urgency of stability management of health product material quality, and take timely measures to meet this requirement.
At present, health product material enterprises are generally small in scale, and the research on the relevant theories of health product material quality management is not yet perfect. They are only limited to meeting the review requirements of Order No. 13 of the State Food and Drug Administration to obtain registration certificates, and then obtain GB/T19001 quality system certification, believing that they have met the stability requirements. In fact, if the quality of health product materials cannot be managed stably according to scientific management methods, the frequency of occurrence of health product material quality defects will be very high, so they can only rely on price advantages to seize the market, bringing greater hidden dangers to the stability of drug quality.
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