Drug packaging for the first time in pharmacopoeia Drug safety foundation to consolidate
On December 1 this year, "Chinese pharmacopoeia" 2015 edition will fully implement, the Chinese medicine packaging materials included in the form of general rules for the first time. Various pharmaceutical enterprise importance not only to the medicine packaging material spurt, at the same time, strengthen the medicine packaging material testing become more common.
"Chinese pharmacopoeia" 2015 edition has realized the historical breakthrough, increase the general requirements for the medicine packaging material guiding principles and guiding principles "pharmaceutical glass materials and containers. Drug packaging for the first time into the "Chinese pharmacopoeia" not only filled the void, improving the system of pharmacopoeia, at the same time, the nation's top drug code must be the medicine packaging material is one of the important status, drugs part of it pushes the medicine packaging material quality, further consolidate the foundation of drug safety control.
Division of national pharmacopoeia committee, deputy director of the HongXiaoXu said that in recent years, the state pharmacopoeia commission standards rise, pay special attention to medicine packaging material from 2009 ~ 2015 medicine packaging standards improve investment funds totaling 24.26 million yuan. "The general requirements for drug packaging guidelines" several drafts before, strive to concise, reflect the essence and finally formed the medicine packaging material definition, classification, basic requirements, the compatibility of the medicine packaging material and drug research, medicine packaging standard framework description.
China pharmaceutical packaging association deputy secretary-general in China think high, medicine packaging materials included in the pharmacopoeia's biggest significance is pointed out the direction for the pharmaceutical enterprises to choose medicine packaging material. For drug packaging enterprise, must improve the quality to meet the requirements of pharmacopoeia.
The adr of incidents in recent years, drug packaging materials and auxiliary materials factors accounted for is higher, the compatibility of the medicine packaging material and drug become the focus of safety concerns. This time, "the general requirements for drug packaging guidelines," specific provision: the compatibility of the medicine packaging material and drug research is the basis of the choice drug packaging, pharmaceutical preparations when choosing medicine packaging material must be the compatibility of the medicine packaging material and drug research... The rules will gradually turn pharmaceutical enterprise price oriented medicine packaging material choice, do not attach importance to basic research "takes doctrine", and drug quality problems after the current situation of pharmaceutical enterprises and packaging mutual buck-passing.
HongXiaoXu said, at present the medicine packaging industry still faces many challenges in the standard system: one is the standard system has not yet been established, the relevant form a complete set of technical regulations, technical requirements, testing means it is not perfect; Second, drug packaging materials production, quality control, safety evaluation, material compatibility, applicability and related technical guidelines to be set; Three is the lack of the management of the whole process of medicine packaging materials and control requirements, including the selection of raw materials for production and control, production process monitoring, medicine packaging materials packaging, transport, storage, validity, etc.; Four is medicine packaging material quality control and final preparation management decoupling control to a certain extent of existence, not form a coherent quality control and safety evaluation system; Five how is medicine packaging material quality control testing program can truly reflect the inner quality level should be in-depth study, the scientific nature and rationality, limit standards and testing technology is reliable).
In fact, our pharmaceutical enterprises long-term formation of the inertial thinking is always pushing country standards rise, take the initiative to improve the standard of enterprise is not much. High in China, points out that almost all foreign pharmacopoeia standard setters from the enterprise, in this way, a more scientific and reasonable standards, better security standards and production is not out of line.
It is understood that the national pharmacopoeia committee is also actively encourage enterprises to participate in setting standards, concentrate the power of the industry to accelerate the perfect standard system.
"Drug packaging materials into the" Chinese pharmacopoeia "is to make up for past standard short board, the important measure of realizing a complete control of pharmaceutical production and guarantee the drug throughout the life cycle conform to the requirements of the standard. This is the breakthrough progress in China pharmacopoeia revision, also with the international advanced level in the beginning of the pharmacopoeia to shorten the distance, will promote a profound impact the quality of drugs." Zhejiang province food and drug inspection institute, director of the hospital pharmaceutical packaging materials, national pharmacopoeia committee YuHui said.
(" in Chinese medicine newspaper)
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