Pharmaceutical packaging: It is ready for the medicinal glass standardized system
Source：Jiangsu Hualan New Pharmaceutical Materials Co., Ltd. Release time：2022-10-12 11:31:46 Author：1719
On "medicinal glass industry developments and standards Forum" which was held by China Pharmaceutical Packaging Association, relevant experts pointed out that, in recent years, medicinal glass industry is developed rapidly in our country, there is more and more attention to the construction of medicinal glass standardized system, which is gradually established and perfected. Industry standard of China medicinal glass dimensions and appearance will be promulgated in the near future, this standard is certain of scientific, nature and practical, which will be a great significance to promote the healthy development of the industry as a whole."
Vice President and Secretary General of China Pharmaceutical Packaging Association, Hung Tsai points out that, in the development history of medicinal glass products, standardization work has always been playing a crucial role. Especially the pharmaceutical packaging standards promulgated by the State Food and Drug Administration (YBB), physical and chemical properties of medicinal glass are highly emphasized, which is of great significance for ensuring the quality and safety for medicines. But YBB standard is using standard, according to international usual mode, list size and specification into recommended projects, set no sampling provisions and determining rules, have less quality description, and do not have the role of guidance on production and judgment based on the product quality level from both supply and demand. This is, to a certain extent, caused the confusion on size, specifications and irregular on appearance of medicinal glass products, and also leaded to a waste of social resources.
Focusing on this situation, starting from July 2005, the professional committee of glass containers in China Pharmaceutical Packaging Association began to develop association standards, recommend industry uniform size and appearance quality. Association made a uniform standard of size and appearance for medical glass products like medicinal glass tube, medicinal glass bottle, glass oral liquid vials.
"Medicinal glass is a kind of packaging material that direct contact with medicine, it takes a large proportion in the area of pharmaceutical packaging materials, and has irreplaceable properties and advantages, its standards have a critical impact on the quality of pharmaceutical packaging and industrial development.” Director of Medicinal Glass Experts Committee in China Pharmaceutical Packaging Association, Vice President of Institute of China Silicate Glass Branch, Shen Changzhi, points out that association standards are important components of standardization system, and it is also important complement to national standards and enterprise standards.
It can guide on the production of medicinal products enterprises; can constrain enterprises ' production and operation conduct, so that it can be comparable with the same product quality level. Since we want to link medicinal glass-related standards with international practices, in addition to chemical stability and biocompatibility issues, it is also necessary to make clear of focus and convergence to producers standards and consumers standards. Only we make a close coordination in science and technology development, standards development and marketing development that can have the market adaptability and international competitiveness.
Hung Tsai stresses that, despite in recent years China made a large development in medicinal glass production, due to low market threshold, compared with other industries, standardization construction of medicinal glass industry has slow pace, there are also many problems for further improvement, perfection for the preliminarily formed medicinal glass standard system, especially it is a need to adapt the high speed development of medicine industry to suit the requirements of international market integration. In addition, in the extent of preparation of standards, content, indicators, use of international standards, and the link with international market, it is a need to make the appropriate adjustments and additions in practice. At the same time, association will also carry out work of energy-saving emission reduction, assessment of cleaner production in the industry.
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