Analysis of the most popular plastic pharmaceutica

Analysis of plastic pharmaceutical packaging in the United States

there are a large number of regulations that plastic packaging and plastic packaging industry must comply with all over the world. Most regulations are not directly aimed at plastic packaging, but are mostly related to job safety, pollution prevention, product trademarks, infringement prevention and other broader contents. This article mainly introduces and discusses the relevant contents of plastic packaging. Generally, the requirements for pharmaceutical industry or other medical products are the most stringent. Including in China, the regulations of the pharmaceutical industry are relatively perfect and strict at present. The second is food packaging, and the third is cosmetics, which has low requirements for most other products

the regulations used to regulate the food, drug and cosmetic packaging industry in the United States are authorized by the federal food, drug and cosmetic code. This code was first passed in 1938, and was revised and promulgated in section 21 of the regulations of the United States. It authorizes the food and drug administration to formulate relevant regulations and promulgate them on the federal regulations (CFR). When amending regulations or formulating new regulations, they should first be submitted to the federal records for public opinion. After the new regulations are formulated, they will also be published in the Journal of federal records, including official notices, executive notices and other documents signed by the president of federal agencies and organizations. Therefore, the new regulations will appear in the next Journal of the federal regulations, which are generally 50 volumes per year

these publications are printed by the Government Printing Office (GPO). At the same time, services can be provided on the bernment printing office

generally, it is more important to understand some specific information in the regulations than the information of the authorization law. For example, it is important to check the federal records and CFR if you want to know whether a certain plastic or other material is permitted by the regulations when it is used for packaging. These information can be accessed through the address of the food and drug administration, which also provides retrieval services. The language used in the regulations is generally complex. It is recommended to consult experts at any time. You can also get help or consulting services from FDA. For food packaging, you can visit food chemical news to get some relevant food chemical information

US medical packaging regulations

drug packaging

regulations require medical products to be certified before being put on the market, that is, manufacturers must provide FDA with sufficient evidence to show that the drug is safe and effective before producing and selling a drug, and establish archives. Of course, the packaging of their products is also one of the testing items. For example, the products must be pasted with the shelf life and stability test results to ensure that the drugs have no toxic and side effects within the shelf life. The stability test requires that the test of drugs should be carried out in the actual packaging where the drugs are located (21cfr211.166) (Note: according to CFR nomenclature 21cfr211.166 means: CFR paragraph 21, Part 211, section 166.)

in the process of formulating the regulations, the food and Drug Administration (FDA) and the United States Pharmacopoeia (USP) will work closely together, because U.S. law stipulates that any sold drugs listed in the USP must comply with USP standards. In the testing of packaging materials, most of them need to comply with the relevant testing standards of ASTM and ISO, and provide testing reports

after the drug is put on the market, if the manufacturer requires to change the packaging and packaging materials in any way, the stability test of the drug must be carried out in the new packaging, and a supplementary instruction of the new drug (NDA) must be provided to FDA. The new packaging can be put into use only after it is approved. There are also relevant provisions for accelerated testing under high temperature and high humidity conditions. The accelerated test is carried out under harsh conditions, accelerating some slow changes that may occur under normal storage conditions. However, even if a new drug is licensed on the basis of accelerated test results, it still needs stability test evidence within the shelf life under normal storage conditions. Therefore, changing drug packaging is a very difficult and complex work. For this reason, in order to make the experimental data accurate, the energy industry absorbed by many drug manufacturers when they were destroyed attaches great importance to the quality of products and packaging, and has done a lot of work and experiments in the early stage of launch. Set up a special laboratory to test drugs and packaging

FDA also allows some packages to be replaced with plastic resins. Generally, the same closed container system test does not only refer to the same kind of plastic, but the same kind of container including plastic formula. Therefore, FDA adopted the procedure set by USP to allow manufacturers to change the packaging before obtaining FDA approval. If the test of approved materials shows that the new plastic varieties selected are the same, the test draft can be used as the basis for judgment. At present, only HDPE, LDPE, pet and propylene glycol pet and other materials have such a test draft. For example, if two kinds of HDPE bottle Varian meet the requirements of the test draft, they can be interchanged. That is, if one of them has been proved to be safe for a specific occasion, the other can also be applied to this occasion. However, the packaging materials can only be interchanged after the stability test proves to be safe

Chinese enterprises need to do a lot of preliminary work to sell drugs in the United States. First, they need to find partners in the United States and establish files in FDA. Only after FDA approval can it be sold in the United States. But at present, the biggest problem for Chinese drugs before entering the market is the inspection of packaging materials. Many materials that can meet national standards at home have encountered layers of resistance abroad. As for the details of the application, this article does not describe, you can seek help from domestic consulting companies

medical device packaging

people may not think that in addition to food, drugs and cosmetics, the code also regulates medical devices. But in fact, the code has been involved in this field since 1938, and the provisions in the 1976 medical device amendment are more stringent, requiring that, like drugs, they must be approved in advance before being put on the market. There are different categories of medical devices, and the corresponding regulations are also different in quantity and type. The expert group divides all medical devices used for human body into three categories:

1) general control

2) special control

3) pre approval

1 devices require reliable identification and pre-sale notice, that is, the manufacturer informs FDA of the products to be put on the market without FDA approval. The pre-sale approval procedures for Category 3 devices are the same as those for drugs and their packaging. Now the regulations on the management of new devices have become more open process control regulations, and it is particularly pointed out that its packaging is also an integral part of the device

China's drug packaging regulations

China's regulations are promulgated and supervised by the State Food and Drug Administration (SFDA), and the specific regulations in the regulations will be continuously improved according to the actual situation. In one case, the end users of drugs and drug packaging materials apply to the state according to the market and use conditions, with the assistance of a qualified Drug Inspection Institute and testing laboratory, and formulate relevant regulations after approval. It takes a lot of time and experiments. The other is that the national drug inspection units directly under the State Food and Drug Administration and other official units work together to formulate corresponding regulations and specifications. For specific information, please check the details on

now China's drug administration law, regulations for the implementation of the drug administration law, regulations for the supervision and administration of medical devices, regulations for the implementation of narcotic drugs and psychotropic substances and other relevant regulations have been promulgated and implemented. For the regulations on packaging materials, please refer to the SFDA standard collection of packaging materials and containers for drugs in direct contact. For specific details, please check the above page or purchase relevant books from various drug inspection offices for reference. However, in terms of specific details, China's laws and regulations still need to be further improved, especially the requirements for the use of packaging materials are not strict, coupled with the rampant production of fake drugs in China, people's life safety is being affected to a certain extent

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