“Recently, raw and supplemental materials for drug packaging are demanded to be teased thoroughly according to the 2015 “Chinese Pharmacopoeia” to be issued”, Song Xue-jie, vice minister of quality department of Yangtze River Pharmaceutical Group told reporters.
2015 “Chinese Pharmacopoeia” will be fully implemented by December 1st this year, in which drug packaging materials are included in in form of general principle for the first time. The pharmaceutical companies not only pay attention spurt to drug packaging materials, but also strengthen detection of drug packaging materials.
Yu Hui, director of institute for pharmaceutical packaging materials of Zhejiang institute for food and drug inspection and member of the state pharmacopoeia, said that drug packaging materials entering into “Chinese Pharmacopoeia” fills the gap and improves the pharmacopoeia system. Meanwhile, the state supreme pharmacopoeia affirms that drug packaging material is an important part of drugs, which will promote an improvement on the quality of drug packaging materials in our country and further consolidate the control basis of drug safety.
Historical Breakthrough
It’s known that the first pharmacopoeia of the People's Republic of China was promulgated in 1993 before which pharmacopoeia of “Chinese Republic” had imitated western country totally. Because production base of drugs in China was weak in the early years of since the founding of new China, drug packaging materials weren’t accepted by the drug regulatory system. There was shortage of standard and insufficient attention. Until drug administration law had been revised in 2001, drug packaging materials were accepted by the drug regulatory system and standards were gradually established. At present, standards of drug packaging materials in our country is composed by drug packaging materials standard (YBB standard) and product registration standard. 2015 “Chinese Pharmacopoeia” has achieved a historic breakthrough, which has added “General Requirements Guidelines for Drug Packaging Materials” and “Guidelines for Pharmaceutical Glass Materials and Containers”.
Hong Xiao-xu, deputy director of comprehensive office of the state pharmacopoeia committee, said that the state pharmacopoeia committee has paid special attention to improvement on drug packaging materials standard in recent years. Fund for improvement on drug packaging materials costs 24.26 million Yuan from 2009 to 2015. After several changes, striving for simplicity and showing its essence, “General Requirements Guidelines for Drug Packaging Materials” has formed a frame description of definition, classification, basic requirements of drug packaging materials, compatibility of drug packaging materials and drugs, drug packaging materials standard.
Gao Yong-hua, deputy secretary general of China Pharmaceutical Packaging Association considers that the most notable significance of the inclusion of drug packaging materials is to provide direction for pharmaceutical enterprises to choose drug packaging materials. For drug packaging materials enterprises, it is necessary to improve the quality to meet the requirements of Pharmacopoeia.
Yu Hui points out that Pharmacopoeia is the highest code for the state pharmaceutical production and quality control and the minimum standard that pharmaceutical production must comply with. In the past, most pharmaceutical enterprises adhere to the market-oriented when choosing drug packaging materials, therefore the quality is often ignored and fund for fundamental research on drug packaging materials is insufficient. In drug misadventures in recent years, the rate of drug packaging materials and auxiliary materials was very high. Compatibility of drug packaging materials and drugs has become the focus of security risks. In this time, “General Requirements Guidelines for Drug Packaging Materials” clearly prescribes that compatibility of drug packaging materials and drugs is the foundation of choosing drug packaging materials and when choosing drug packaging materials for pharmaceutic preparation, compatibility of drug packaging materials and drugs must be studied......This regulation will gradually transform the status quo that pharmaceutical enterprises adhere to the market-oriented when choosing drug packaging materials and "take-in" that pay no attention to basic research, and pharmaceutical enterprises and packaging materials enterprises blame each other for quality problems of drugs.
In line with international markets
Hong Xiao-xu shows that drug packaging materials industry still faces many challenges on standards system: one is that standard system has not yet been established and related matching technical regulations, technical requirements, test methods are still imperfect. The second is that production, quality control, safety evaluation, supplementary materials compatibility, applicability of drug packaging materials and other relevant technical guidelines are serious problems. The third is lack of management and control requirements of the whole process of drug packaging materials, including selection and control of raw materials for production, monitoring of production process and packaging, transportation, preservation and period of validity of drug packaging materials. The fourth is that there are decoupling phenomena on management of quality control of drug packaging materials and control of final preparation drugs and consistent quality control and safety evaluation system haven’t yet formed. The fifth is that it should be further studied that how test items of quality control of drug packaging materials could truly reflect internal quality level.
Yu Hui shows that both “General Requirements Guidelines for Drug Packaging Materials” and “Guidelines for Pharmaceutical Glass Materials and Containers” included in 2015 “Chinese Pharmacopoeia” are framework technical requirements which haven’t involved specific breed standards. Due to the weak fundamental research in our country, control measures for quality factors of drug packaging materials are still in study. Therefore, the included varieties of drug packaging materials still need be top designed and well funded by the state pharmacopoeia committee and need careful deployment of the China inspection institute, vigorous cooperation of brother units and fruitful work mechanism. It’s known that now appendixes of the US pharmacopoeia, British pharmacopoeia, European pharmacopoeia and Japanese pharmacopoeia have collected general technical requirements of drug packaging materials, mainly including nature, chemical and biological properties of materials, glass, plastic and rubber. However, at present, only production process of glass and study on its chemical properties are relatively mature in our country. Therefore, “Guidelines for Pharmaceutical Glass Materials and Containers” has been released firstly.
Hong Xiao-xu shows that formation mechanism of drug packaging materials standard should be based on enterprises instead of being supported by government. Mature formation mechanism for standard are, in order from high to low: industrial standards——recommended standards——pharmacopoeia standards——enterprise internal control standards, that is to say progress of the standards comes from enterprises. Only enterprises have been given experimental verification can give rise to pharmacopoeia standard.
In fact, habitual thinking formed over a long period of time with pharmaceutical enterprises in our country is that standards are often a state-driven improvement, but very few enterprises having the initiative to improve standards. Gao Yong-hua points out almost entirely foreign pharmacopoeia standard-setters come from enterprises. Standards established are more scientific and reasonable which could better keep standards from skipping from the production.
It is said that the state pharmacopoeia committee is also trying to encourage enterprises to participate in standards at present, gathering the power in this industry to accelerate the perfects of standard system.
“Drug packaging materials entering into ‘Chinese Pharmacopoeia’ is an important step for remedying short board of the past standards, realizing a complete control of drugs production and ensuring the entire life cycle of drugs could meet standards. This is a breakthrough advance of Chinese Pharmacopoeia revision. It’s also an important start of shortening the distance with advanced international pharmacopoeia levels, which is sure to exert far-reaching influence on the improvement of drug quality.”Yu Hui said. (Source: China Medical News)
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