The design of the hottest packaging shall comply w

2022-08-07
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The packaging design shall comply with the regulations on the management of drug packaging (I)

the supervision and management of packaging materials and containers, drug packaging, drug labels and instructions that directly contact drugs are specified. The revised Drug Administration Law has added provisions on the supervision of drug packaging materials and deleted the provisions of Article 37 of the original law on the sub packaging of drugs by drug handling enterprises. Drug repacking should have been carried out in drug manufacturing enterprises. At the early stage of the implementation of the drug administration law, due to the insufficient production capacity of preparations in China at that time and the large variety of preparations prepared by hospitals, in order to meet the market demand and ensure drug supply, it is necessary to agree that drug handling enterprises repack bulk drugs for hospital formulas. The original law makes corresponding provisions on the requirements of drug handling enterprises for repacking drugs. Due to the rapid development of China's pharmaceutical industry, at present, the production capacity of preparations has been able to meet the supply, and the sub packaging of drugs by pharmaceutical trading enterprises has rarely occurred. This provision is no longer necessary. Therefore, Article 37 of the original law on sub packaging of drugs by pharmaceutical trading enterprises has been deleted. Article 52 the packaging materials and containers that come into direct contact with drugs must meet the requirements for medicinal use and the standards for safeguarding human health and safety, and shall be examined and approved by the drug regulatory department at the same time as the drugs are examined and approved. Drug producing enterprises shall not use unapproved packaging materials and containers that directly contact drugs. For unqualified packaging materials and containers that have direct contact with drugs, the drug regulatory department shall order them to stop using. [definition] this article is the basic requirement for the product quality of packaging materials and containers (hereinafter referred to as drug packaging materials, the same below) in direct contact with drugs. It is the guideline for pharmaceutical enterprises and hospital preparation rooms to use drug packaging materials. It also defines the approval responsibilities of drug regulatory departments for drug packaging materials standards and products, and the disposal limits for unqualified drug packaging materials and illegal use. The drug packaging materials subject to approval referred to in this article do not include the packaging materials and containers that directly contact drugs for circulation in the production workshop of the pharmaceutical factory and the preparation room of the hospital. Due to the particularity and importance of packaging materials in direct contact with drugs, it is necessary to add this provision from the perspective of reality. This article mainly includes three aspects: first, the packaging materials and containers that are in direct contact with drugs must meet the pharmaceutical requirements, meet the standards to ensure human health and safety, and be approved by the drug regulatory department when approving drugs. 1. packaging materials and containers in direct contact with drugs are an integral part of drugs, which accompany the whole process of drug production, circulation and use. Especially for pharmaceutical preparations, some dosage forms exist in chain stores (such as capsules, aerosols, water injections, etc.) depending on packaging. Due to different drug packaging materials, container composition, selected raw and auxiliary materials and production processes, some components may be dissolved by the drugs they come into contact with, or interact with the drugs, or be corroded by the drugs for a long time, which will directly affect the drug quality. Moreover, some have hidden dangers on drug quality and human body (i.e. problems cannot be found in time through routine inspection on drug quality and human body). For example, ampoules and infusion bottles (bags), if different formulations and production processes are not adopted for different drugs, components will often be dissolved and glass flakes will fall off, which can not be found during routine drug inspection. For example, the foreign protein dissolved from the natural rubber plug may be a heat source for human body, and the dissolved pyridine compounds are certain factors causing cancer, teratogenesis and mutation, The tiny glass flake is a hidden danger of blocking blood vessels, forming thrombus or pulmonary granuloma, and so on. On the other hand, due to the variety of drugs and the complexity of effective active groups, the requirements for packaging materials and containers in direct contact with them are much higher than those for other products. 2. China's pharmaceutical packaging material manufacturers and products are relatively backward, the overall level of pharmaceutical packaging is low, and the contribution of packaging to the development of pharmaceutical economy is low. Although there are about 1000 enterprises in China, which produce medicinal glass. 2. Control system maintenance: more than 60 varieties of packaging materials and containers that directly contact drugs in five categories: glass, metal, medicinal gelatin products, rubber, plastics (containers, sheets, films) and their composite sheets (films). The annual output value is about 15billion yuan. However, at present, the overall level of drug packaging in China is significantly lower than that in developed countries, including packaging quality, packaging material quality and the contribution rate of packaging to the pharmaceutical economy. In developed countries, the proportion of general varieties of packaging in the value of drugs is 15-25%, and some varieties account for more than 30%. In China, it only accounts for about 8-9%. Most of the existing pharmaceutical packaging material production enterprises in China are township collective enterprises, which are small in scale, low in personnel quality, equipment, technology and management level, and unstable in product quality. In 1998, the China Pharmaceutical Packaging Association conducted a spot check on the quality of some pharmaceutical glass tubes and ampoules. The results showed that 30% of the products were unqualified, and the unqualified rate of individual items was 38%. The water resistance rate of the two products was poor, and the phenomenon of tablets falling off was serious, leaving hidden dangers for safe drug use. 3. for a long time, China has not set up a supervision system for imported drug packaging materials. With the development of China's pharmaceutical industry and the growth of imported drug packaging materials, especially since the former State Pharmaceutical Administration implemented the license system for the production of domestic drug packaging materials in 1992, domestic enterprises require that the state should set up an access system for imported products in terms of equal treatment. At the same time, in the actual work, it is also found that the quality of some imported products is unstable. Especially after China's entry into WTO, the import of drug packaging materials may increase by a large margin. In order to control the quality and obtain the same treatment from domestic and foreign enterprises, it is also necessary to set up access procedures for imported drug packaging products. 4. internationally, the drug administration authorities of various countries generally attach great importance to the supervision of drug packaging and drug packaging materials. However, the supervision of drug packaging materials in China was insufficient due to the lack of legal basis before the amendment of the drug administration law. Therefore, the quality is not high and does not meet the standards. Recently, the team's achievements have been selected in the large-scale literature special series of "scientific and technological innovation leads to surpassing development" of the Chinese Academy of Sciences, and the drug packaging products are common; The problem of using unqualified drug packaging materials or using unapproved drug packaging materials has not been solved; The promotion and application of Youxin drug packaging materials is slow, and it is difficult to eliminate some backward, inconvenient to use, or even affect the drug quality. Some are still affecting the drug quality. Therefore, in combination with China's national conditions, in order to improve the quality of packaging materials and containers that directly contact drugs, ensure the safety and effectiveness of drugs, and promote the healthy development of the pharmaceutical economy, strengthen the supervision and management of this part of drug packaging products and their use, and take effective measures to put forward clear requirements in this paragraph of the law. The drug regulatory department must organize the formulation, approval and promulgation of drug packaging material standards from the perspective of meeting pharmaceutical requirements and ensuring human health and safety. The standards should include product quality, inspection and testing methods and quality assurance system. When approving a new drug, the packaging material of the new drug shall be approved at the same time, and the safety compatibility data of the packaging material and the drug shall be reviewed at the same time. Second, drug manufacturing enterprises shall not use unapproved packaging materials and containers that have direct contact with drugs. Compared with foreign advanced pharmaceutical companies, Chinese pharmaceutical enterprises generally do not have a clear understanding of the relationship between packaging, packaging materials and drug quality, and do not pay enough attention to the research on the interaction between drug packaging, packaging materials and drugs. They often choose inferior packaging materials in order to reduce costs. Some backward packaging forms and packaging technologies are still adopted in China's pharmaceutical enterprises. This prohibition clause has been added to this Law in order to improve the level of drug packaging in China and ensure the quality of drugs and the safety of people's use of drugs. Third, the pharmaceutical supervisory and administrative department shall order the unqualified packaging materials and containers that have direct contact with pharmaceuticals to stop using. Drug packaging materials that do not meet the standards shall be stopped using under the supervision of the drug regulatory department. Drug packaging materials that have not been examined and approved shall not be used. If unqualified packaging materials and containers that directly contact drugs are purchased, the drug regulatory department shall order them to stop using them. If drugs are packaged with unapproved drug packaging materials that are in direct contact with drugs, the drugs will be treated as inferior drugs in accordance with Article 49 (4) of the drug administration law. Article 53 the packaging of drugs must meet the requirements of drug quality and facilitate storage, transportation and medical use. Chinese medicinal materials must be packaged for shipment. On each package, the product name, place of origin, date and transfer out unit must be indicated, and the mark of qualified quality must be attached. [interpretation] this article is about the purpose of selecting the packaging of drugs and the provisions on the transportation packaging of traditional Chinese medicine. Drug packaging plays a role in protecting drug quality and facilitating medical use during the period of drug validity from the production, storage and transportation of drugs to the completion of drug use. Therefore, when selecting drug packaging, it is necessary to select packaging materials and containers with good shielding and blocking performance against light, heat, freezing, radiation, oxygen, water vapor and other factors, good self stability, and no interaction or mutual migration with drugs according to the characteristics of drugs and the material, formula and production process of drug packaging materials. The packaging of drugs is divided into inner packaging and outer packaging. Inner packaging refers to the packaging directly in contact with drugs (such as ampoules, injection bottles, tablets or capsules, blister packaging aluminum foil, etc.). For the change of the materials and containers (drug packaging materials) of the internal packaging of drugs, a stability test shall be conducted according to the materials of the selected drug packaging materials to investigate the compatibility between the drug packaging materials and drugs. Outer packaging refers to the packaging other than inner packaging, which is divided into medium packaging and large packaging from the inside out. The outer package shall be selected according to the characteristics of the drug, which is not easy to be damaged, moisture-proof, antifreeze and insect proof, so as to ensure the quality of the drug during transportation and storage. Due to the traditional customs in China, the shipment of Chinese medicinal materials is often not packed, and there are no quality assurance elements such as product name, place of origin, the day before, transfer out unit, etc. Thus, it is difficult to identify traditional Chinese medicine and cannot be investigated for quality problems. In the future, the enforcement of this article should be strengthened to ensure the quality of traditional Chinese medicine during storage and transportation. Article 54 drug packages must be printed or pasted with labels and instructions in accordance with regulations. The general name, composition, specification, manufacturer, approval number, product batch number, production date of the drug must be indicated on the label or instruction manual. The pressure testing machine and constant stress pressure testing machine are very common in the market, their validity period, indications or functions, usage, dosage, contraindications, adverse reactions and precautions. The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs must bear the prescribed marks. [interpretation] this article is a regulation on the management of the contents of labels and instructions on drug packages. This regulation specifies the contents that must be reflected on the packaging labels and instructions of general drugs and special drugs. This article is an amendment to Article 37 of the technical drug law. The original law stipulates that "drug packages must be labeled and attached with instructions in accordance with regulations." "Label or

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