In view of this situation, starting in July 2005, the China Glass Packaging Professional Committee of the Pharmaceutical Packaging Association began to organize the development of association standards, recommending industry uniform specifications and appearance quality. The association standard regulates the specifications, dimensions and appearance of pharmaceutical glass products such as pharmaceutical glass tubes, medicinal glass infusion bottles, and glass-controlled oral liquid bottles.
Cai Hong, vice president and secretary-general of the China Pharmaceutical Packaging Association, pointed out that standardization work has played a crucial role in the history of the development of medicinal glass products. In particular, the Pharmaceutical Packaging Standard (YBB) promulgated by the State Food and Drug Administration emphasizes the physical and chemical properties of medicinal glass and is of great significance for ensuring the quality and safety of medicines. However, the YBB standard is the standard of use. According to the international standard, the specification size is included in the recommended project, the sampling plan and the judgment rule clause are not set, the description of the appearance quality is less, there is no guidance for the production of the enterprise, and the supply and demand sides of the product The quality of the basis for the determination of the role. This has caused a certain degree of confusion in the specification and size of medical glass products and the appearance of non-standard, in addition, it also led to the waste of social resources.
"Medicinal glass is a packaging material that directly contacts pharmaceuticals. It has a large proportion in the field of pharmaceutical packaging materials and has irreplaceable performance and advantages. Its standards have a crucial influence on the quality of pharmaceutical packaging and the development of the industry." Shen Changzhi, director of the Pharmaceutical Glass Experts Committee of the Packaging Association and vice chairman of the China Silicate Academy's Glass Branch, pointed out that the association standard is an important part of the standardization system and an important supplement to national standards and corporate standards. It can play a guiding role in the production of pharmaceutical glass products companies, but also can constrain the company's production and operation behavior, so that the quality level of similar products can be comparable. The relevant standards of pharmaceutical glass in China should be in line with international standards. In addition to chemical stability and biocompatibility issues, the focus and convergence of producer standards and user standards must also be clarified. Only by closely coordinating scientific and technological development, standard development, and market development can standards be marketable and internationally competitive.
Cai Hong emphasized that although China's medical glass production has made great progress in recent years, due to low market thresholds and other reasons, compared with other industries, the pace of standardization in the pharmaceutical glass industry has been slow, and medicines that have been initially formed have been developed. There are still many problems that need to be further improved, improved and perfected in the glass standard system, especially in order to adapt to the rapid development of the pharmaceutical industry and to meet the requirements of international market integration. In addition, in the standard preparation, content, indicators and the use of international standards, and the degree of convergence with the international market, all need to make appropriate adjustments and supplements in practice. At the same time, the association will also work in the industry on energy-saving emission reduction, assessment of corporate clean production and other aspects.
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