In June 2009, a drug regulatory agency discovered during daily supervision and inspection that the Coenzyme A for injection used in batch D produced by the C manufacturer in Hospital B was packaged in ampoules, and the Coenzyme A dosage form for injection was powder injection. According to the investigation, the packaging material Ampoule used for injection coenzyme A for batch D was a legal drug packaging material with a drug packaging material registration certificate. After verification, the application data of coenzyme A injection showed that the drug packaging material was a vial bottle.
Disagreement:
On June 2, 2002, the State Economic and Trade Commission issued the “Catalogue of Eliminating Outdated Production Capacity, Processes, and Products†(the third batch), in which the phase out of the use of Ampoule Packing Powder Injection was clearly established. The specific implementation time was July 1, 2002. . The coenzyme A used for injection of powder injections produced by the C manufacturer, batch D, was still used in Ampoules after the state had phased out the use of ampoules for injections. This behavior was clearly illegal, but law enforcement officials had produced qualitative and The following three comments:
The first opinion is that the batch of drugs can be characterized as inferior drugs. The state has already phased out the use of Ampoule powder injections. The declaration materials provided by enterprises when applying for drug registration also show that the packaging material for Coenzyme A pharmaceuticals for injection is vials. In this case, the company still uses coenzyme A for injections for ampoule packaging. In accordance with Article 49(3)(4) of the “Drug Administration Law†in the case of “non-approved packaging materials and containers that come into direct contact with drugsâ€, it is not possible to mechanically consider that the drug packaging material products themselves have not been approved for approval. The number is in line with this situation.
The second opinion is that treatment should be carried out in accordance with the Administrative Measures for Packaging Materials and Containers Directly in Contact with Drugs. The national elimination of ampoules for powder injection is because it is not suitable for packaging powder injections. Therefore, for the powder injections in this case, ampoules are obviously unqualified drug packaging materials, and the management methods for packaging materials and containers for direct contact with drugs should be handled. Article 65 stipulates that "if the use of substandard drug packaging materials is used, the drug regulatory department shall order them to stop using them and impose a fine of no less than 10,000 yuan but no more than 30,000 yuan, and the drug packaging materials of the packaged drugs shall be immediately Recovered and supervised by the drug regulatory authorities."
The third opinion is that the batch of drugs cannot be characterized as inferior drugs. Although the country has phased out the use of ampoule powder injections, Ampoule has not been eliminated as a drug packaging material but has been widely applied to other pharmaceutical products such as water injections. The drug packaging material used in Coenzyme A for injections of batch number D is an amphetamine. The legal drug packaging materials for the registration of packaging materials do not meet the requirements of Article 49(3)(4) of the “Drug Administration Law†for the “unapproved packaging materials and containers for direct contact with drugs†and should not be qualified as Poor medicine.
Comment:
The author believes that before analyzing the case, it is necessary to give a brief description of the safety of the ampoule and vials and their influence on the quality of the drug. In 2002, the State Economic and Trade Commission eliminated the Ampoule Packing Powder as an outdated production process in the “Catalogue of Outdated Production Capacity, Processes and Products†(Third Batch), and replaced it with a vial of medicine packaging material. Xilin bottle is also called soda-lime glass molded injection bottle. It is a kind of small bottle sealed by rubber stopper. It has brown, transparent and other types. It is generally of neutral glass material. Ampoule is a thin sealed bottle glass bottleneck, which is generally used as a bottle neck. Iodine bottles, injection bottles, oral liquid bottles, etc., in the price of vials higher than ampoules.
The reason why the country eliminates ampoules is that the ampoules currently used by Chinese companies are generally low borosilicate glass, and their quality is poor, glass swarf is relatively large, and the phenomenon of detachment is easy to occur, which does not meet the requirements of international neutral glass. The packaging materials and containers that are in direct contact with the drug are an integral part of the drug. With the whole process of drug production, distribution and use, their quality directly determines whether they contaminate the drug in the container and whether it affects the stability of the drug. Due to the differences in the pharmaceutical packaging materials, composition formulas of the containers, selected raw materials, and different production processes, some components may be dissolved by the exposed drugs, interact with the drugs, or be directly immersed and eroded by the drugs to directly affect the drug quality. Ampoules are packaging materials and containers that are often exposed to components that are exposed to the drug and are susceptible to glass dislodging. However, because this phenomenon is difficult to detect during routine drug testing, fine glass removal is May cause blood vessel thrombosis or granulomatosis in the patient, which may affect the patient's life safety. Therefore, packaging materials and containers that come into direct contact with pharmaceuticals are critical to the quality and safety of pharmaceuticals, and it is only natural that ampoules are eliminated.
In this case, C-manufacturers used the cheaper Ampoules to pack powder injections. This reflected the company's unclear understanding of the relationship between drug packaging, packaging materials and drug quality. The use of phase-out packaging materials for the packaging of coenzyme A for injection in order to reduce production costs poses serious risks to the safety of public drug use and increases the unsafe factors in the use of drugs. Therefore, it must be severely combated. However, the special feature of this case is that although Ampoule was eliminated in the powder injection package, it has not been eliminated as a pharmaceutical packaging material. It can be seen from the facts that the packaging material Ampoule used for the injection of coenzyme A for Batch D is a legal drug packaging material with a drug packaging material registration certificate. In this case, whether the drug is still in compliance with Article 49 of the Drug Administration Act Subparagraph (4) of Subparagraph 3 of the "Unauthorized Packaging Materials and Containers Directly Contacted" Provisions?
The compliance with the provisions of Article 49(3)(4) of the Drug Administration Law depends on how to understand the meaning of “unapproved packaging materials and containers that come into direct contact with drugsâ€. The article itself is not complicated, but the key to understanding is the word "approved." With regard to the understanding of “approvalâ€, law enforcement personnel are prone to “approval†for “unauthorized production, import, etc.†in accordance with Article 48(3)(2) of the “Drug Administration Lawâ€. Meaning equivalent means the approval of the product itself and the approval number. If this understanding is established, then the circumstances in this case obviously do not comply with the provisions of the article, because the security is a legal packaging material that has obtained a registration certificate for pharmaceutical packaging materials. It seems that the first opinion is correct.
Article 52 of the Drug Administration Law stipulates that: "The packaging materials and containers that are in direct contact with drugs must meet the requirements for pharmaceuticals and meet the standards for the protection of human health and safety, and should be reviewed and approved by the drug regulatory authority. It is also approved.†The second paragraph of the article states that “drug production enterprises must not use unapproved packaging materials and containers that come into direct contact with drugsâ€. This clause states that there is a certain correlation between “approval†and “approvalâ€. The interpretation of the “Drug Management Law†is: “In accordance with the provisions of this article, packaging materials and containers that come in direct contact with drugs shall be examined and approved by the drug regulatory authority when they approve drugs. Drug production enterprises are reported to the drug regulatory authorities for approval according to law. In the production of new drugs or generic drugs, the packaging materials and containers that are to be used for direct contact with the drugs shall be submitted to the drug regulatory department for approval at the same time, and they shall be used only after approval; the quality indicators of packaging materials and containers that have not been approved for direct contact with drugs Whether it meets the requirements and standards of drugs and has not been confirmed in accordance with the law, in order to ensure the quality of drugs and ensure the safety of people's drugs, this article clearly stipulates that drug manufacturers are prohibited from using unapproved direct contact with packaging materials and containers; Unapproved drugs that come into direct contact with the packaging materials and containers of drugs shall be treated as inferior drugs according to the provisions of Article 49 of this Law." It can be seen from this that the "approval" in the article should contain two meanings. : First, the packaging materials and containers that come into direct contact with the drug should be approved, Number of approval to products; packaging materials and containers Second, direct contact with drugs should be the drug regulatory authorities in approving the drug for approval in conjunction varieties. Based on this, although Anbao in this case has a drug packaging material registration certificate, it does not meet the above-mentioned meaning of the second layer, so it can be qualified as Article 49(3)(4) of the Drug Administration Law. The prescribed "unapproved packaging materials and containers for direct contact with drugs" and the coenzyme A for injections packaged with the ampoule should be characterized as inferior drugs.
To sum up, the second opinion is correct, and the first opinion is one-sided. The third opinion is that the use of unqualified packaging materials should be handled in accordance with Article 65 of the "Measures for the Management of Packaging Materials and Containers Directly Contacted with Pharmaceuticals." This understanding is incorrect. Since the qualification of unqualified drug packages requires statutory test reports to be quantifiable, in this sense, it is not appropriate to apply this provision to handle this case.
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