Cai Hong, Vice President and Secretary of CPPA, indicated that the standardized work is always essential in the development history of pharmaceutical glass products. Especially the YBB standard (pharmaceutical packaging standard) issued by  State Food and Drug Administration,P.R.China, in which the physical and chemical performances of pharmaceutical glass are emphasized, thus to guarantee the quality and use safety of pharmaceuticals. However, YBB standard is just a standard in utilization. According to the international mode, it is not effective to direct the enterprise’s production and judge the product quality level for both buyer and supplier if no sampling plan or judgment rule has been stipulated or there is insufficient description about the appearance quality. To some extent, this will result in disordered specification and size as well as nonstandard appearance of pharmaceutical glass product. Additionally, social resources will be wasted.

Under such circumstance, the Glass Vessel Committee of CPPA has begun to organize and frame the association standard, recommending the unified specification, size and appearance quality for the industry since July 2005. The association standard sets up a uniform criteria on specification, size and appearance of pharmaceutical glass products like pharmaceutical glass tube, pharmaceutical glass infusion bottle and glass bottle of oral liquid.

“Pharmaceutical glass is the packaging material which directly contacts the pharmaceuticals. It occupies a large proportion in the field of pharmaceutical packaging materials with an irreplaceable performance and advantage. The standardization for pharmaceutical glass will greatly influence the quality of pharmaceutical packaging and the development of this industry.” Shen Changzhi, Director of the Glass Vessel Committee of CPPA and Vice Chairman of Glass Sub-committee of Chinese Ceramic Society, commented that association standard was an integral part of standardization system as well as an important supplement for the national standard and enterprise standard. It can not only guide the production of pharmaceutical glass product manufacturers, but also restrain their production and business operation. Meanwhile, it could also set a feasible quality comparison standard for similar products. Apart from the chemical stability and biological compatibility, the related standards for China pharmaceutical glass should specify the particular emphasis and cohesion between producers’ standard and users’ in order to be in line with the international standard. Should the science and technology development and standard research go hand in hand with the market access, such standard would be capable in market competition both at home and abroad.

Cai Hong also highlighted, the production of pharmaceutical glass in China has gained a great development in recent years. However, due to a low market qualification, the standardization process for the pharmaceutical glass industry lags behind other industries, The preliminary pharmaceutical glass standard system needs further improvement in many aspects, especially in meeting the challenge from the rapid development of pharmaceutical industry and the requirements of market globalization. Additionally, proper adjustment and supplement should be done not only in the aspects of the compilation, content and index of standard, but also in the aspects of international standard adoption and the integration with the international market. Meanwhile, the association will take measures to accelerate energy saving, emission reduction and assessment of enterprises’ green production within the industry.

From: www.cnpharm.cn