On Quality Stability Management of Pharmaceutical Packages Based on Cybernetics
Time:2019.07.11 Source: Clicks:

Requirements for Quality Stability of Pharmaceutical Packages

Article 3 of Chapter I of the Regulations on the Management of Pharmaceutical Quality Production (Revised in 2010) stipulates that "These Regulations shall be regarded as quality management"

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

Article 6 of Chapter II stipulates that "senior managers of enterprises shall ensure the achievement of established quality objectives, and personnel at different levels, suppliers and distributors shall participate in and assume their respective responsibilities."

In fact, the sustained stability of drug quality is not only a requirement for the quality of drug production, but also a requirement for the quality of packaging materials directly in contact with drugs. This is because the quality of medicines depends on many factors, such as production process, raw and auxiliary materials, packaging materials, production equipment, production environment, etc. Among them, direct contact with packaging materials of medicines is one of the important factors. Moreover, in the "Regulations for the Management of Pharmaceutical Quality Production (2010 Revision)", the requirements for the management and control of packaging materials directly in contact with drugs are the same as those of raw and auxiliary materials.

In order to achieve this requirement, pharmaceutical enterprises must decompose the responsibility, in which the quality responsibility of pharmaceutical packaging is mainly assumed by pharmaceutical packaging enterprises.

On the day of the promulgation of the "Standards for the Management of Pharmaceutical Quality Production (Revised in 2010)", the State Food and Drug Administration issued a circular that from March 1, 2011, all newly built (revamped and expanded) workshops of pharmaceutical and pharmaceutical manufacturing enterprises should meet the requirements of the "Standards for the Management of Pharmaceutical Quality Production (Revised in 2010)". The production of aseptic drugs such as blood products, vaccines and injections by existing pharmaceutical manufacturers should meet the requirements of the Regulations on the Quality Production and Management of Drugs (revised in 2010) by December 31, 2013. The production of other categories of drugs should meet the requirements of the Regulations on the Quality of Drug Production Management (2010 Revision) by December 31, 2015.

In the face of many national requirements for pharmaceutical manufacturers, pharmaceutical packaging enterprises, as the main suppliers of pharmaceutical manufacturers, must fully recognize the importance and urgency of quality stability management of pharmaceutical packaging materials, and take timely measures to meet this requirement.

At present, the scale of pharmaceutical packaging enterprises is generally small, and the research on the related theory of quality management of pharmaceutical packaging materials is not perfect, which is limited to

To meet the requirements of the inspection of Decree No. 13 of the State Food and Drug Administration and obtain the registration certificate, and then pass the GB/T19001 quality system certification, it is considered that the quality stability requirements have been met. In fact, if we can't manage the stability of the quality of the drug package according to the scientific management method, the frequency of the quality defects of the drug package is very high, so we can only rely on the price advantage to seize the market, and the stability of the quality of the drug delivery brings great hidden dangers.

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