The role of the international certification and wa

2022-07-24
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Pharmaceutical packaging: the role of the international certification warming association is highlighted

our products are undergoing international certification. Today, I specially come to listen to the Forum on international certification of pharmaceutical packaging. Recently, liguohua, deputy general manager of Gree pharmaceutical from Qingdao, Shandong, made the above remarks at the special forum on pharmaceutical packaging of the 58th China International API trade fair

the pharmaceutical packaging forum held by China Pharmaceutical Packaging Association is a highlight of the API trade fair. The theme of the forum is the registration of the U.S. Food and Drug Administration (FDA), which covers the introduction of the drug file management system, how the U.S. pharmaceutical companies and FDA use the three types of drug files, and how drug manufacturers obtain FDA certification. On the same day, we saw that the forum had high conductivity, reduced friction, transparent addition, wear resistance and other properties, the forum was extremely hot, the conference room was full, and packaging enterprises and pharmaceutical enterprises listened to the lecture with great interest

the figure of China Pharmaceutical Packaging Association also means that China high speed railway has a wide international market space. Caihong, vice president and Secretary General of the association, said that the reason why the theme of this packaging forum is focused on international certification is that more and more Chinese pharmaceutical products have gone abroad for international certification, and the importance of packaging materials, as one of the necessary conditions for international certification, has also been widely recognized

the United States attaches importance to the certification of packaging materials

it is understood that the application of the American drug archive system began in the 1960s, and the packaging materials belong to three types of drug archives. At present, the FDA station lists about 1773 active class III drug archives, and Chinese enterprises have 5 class III drug archives. Edmckinley, the regulatory affairs manager of O-I Plastics Group, said that the purpose of establishing the drug file system is to preserve the confidential or private information that the manufacturers of drugs, biological products or packaging materials may need to refer to when submitting relevant declarations to FDA. For pharmaceutical packaging materials, the industry guidance - container closure system for packaging human drugs and biological agents - chemical, production and control documents (hereinafter referred to as container closure guidance) issued by FDA in may1999 is the most comprehensive regulatory guidance for the container closure system for pharmaceutical packaging. The guidance stipulates that the main container closure system used for various dosage forms of drugs and biological products shall submit detailed information to FDA. This information shall include a description of each component of the vessel closure system, the materials used in their respective production and relevant functional information. Because the container closure system has a potential impact on the safety and efficacy of drugs, the expansion of the effectiveness of regulations and approved data testing to the development and utilization of testing instruments has become a normal process, which has strict requirements on the manufacturers of packaging materials and their production auxiliary materials

the actual situation in the United States is that FDA has set a higher standard evaluation on packaging than drug raw materials, and it is easier to change the suppliers of drug raw materials than to evaluate and change the packaging materials. The drug evaluation and Research Center has much more requirements for packaging containers than for drug raw materials. Edmckinley said

Sheng suling, an expert from Wyeth, introduced the production verification and procedures for drugs and packaging in the United States. She said that drug production and operation include three main links: R & D, production and marketing. In production, the key points of ogd/fda review (anda) include: chemical/microbial control of physiological response equivalence, production, control, GMP verification plant and packaging instructions. It can be seen that drug packaging is highly valued in the United States

the domestic packaging material market is getting hotter

with the rapid development of the domestic pharmaceutical industry, helping customers achieve a win-win situation and enter the international mainstream market has become the development goal of many Chinese enterprises. Since 2002, the number of drug substance varieties in China that have obtained DMF documents has increased significantly. At present, more than 300 varieties have obtained DMF documents (the documents submitted to FDA), which also puts forward new requirements for the pharmaceutical packaging industry

it can be seen from the packaging and excipients Trade Fair held at the same time with this API trade fair that the domestic packaging industry is developing towards standardization and scale. Shandong Pharmaceutical glass, Hubei Huaqiang, Jiangsu Runde and other enterprises all appeared at the fair with a new look. The organizer of the fair revealed that this year, the special booth of packaging materials enterprises is more than that of previous years, because enterprises pay more attention to brand and image

at the same time, China's pharmaceutical packaging materials and auxiliary materials market has also attracted more foreign-funded enterprises. Shanghai kalekang company, which specializes in the production of coating accessories, recently announced that the production base established in Shanghai with an investment of several million dollars will be completed in the near future. The president of kalekang Asia Pacific region also personally met with customers at the exhibition. He said that China is a big market, and kalekang is willing to provide services for Chinese pharmaceutical products to pass international certification. At present, kalekang has established a research and development institution for the coating of traditional Chinese medicine in Shanghai, and will continue to increase investment in the Chinese market in the future

Caihong said that with the development of the pharmaceutical industry and the increasing attention of the state to drug safety issues, the packaging industry will surely usher in the spring of development, and industry associations will also play their due role. Similar forums and seminars will continue to be held to help relevant enterprises master information and improve their level

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