Medical Packaging Regulation Can Not Be Ignored "blind Spot" - Medical Packaging,

Medical Packaging Are an integral part of the drugs

, which along with drug production, distribution and use of the whole process. As part of the Medical Packaging quality problems, including material in some of the drugs may lead to dissolution of harmful substances, or with drugs in the reaction of some components directly affect the Drug Quality Therefore, the quality of Medical Packaging pros and cons the people directly related to the medication Security . However, with the drug quality Management Compared to the current Medical Packaging quality management in China lagged behind even the regulatory "blind spots." Below to Oral Aluminum bottle cap for a brief analysis of an example.

Question 1: External Package Logo Does not match with the actual state

Used Pharmaceutical Packaging The oral liquid bottle cap is not an independent use of aluminum, aluminum must be added between the cap and the liquid liner Stopper Or pad, isolated play, sealing role. Current aluminum cover medicinal and pharmaceutical stopper, the State Medical Packaging registration certificate issued separately. Therefore, pharmaceutical companies need to buy separately from legitimate businesses. But in oral liquid manufacturing operation, for technical and cost considerations, pharmaceutical companies can not buy from a manufacturer of aluminum cap aluminum cap, and from manufacturers purchase rubber plug rubber plug, and finally assembled together for the packaging Oral.

Now General Approach is: direct purchase of pharmaceutical companies hope to have assembled stopper of the aluminum cap, and Medical Packaging manufacturers have to this request, provide oral liquid aluminum cap also with different materials within the plug. Plug and aluminum cap in the process of final assembly production companies to complete the aluminum cap, which had aluminum cap factory is a compound of two Medical Packaging products.

Under "direct contact with drugs Packaging materials And Container Management Measures "(Board Order No. 13), when used in the aluminum cover medical stopper must have" Medical Packaging Slip ", the relevant standards. However, oral aluminum cap manufacturers often made of aluminum cover of "Medical Packaging Slip", which is purchased plug, factory product packaging marked only aluminum cover name, batch number and the corresponding Medical Packaging of registration No, resulting in sales of state does not match the actual product, and can not be traced back within the plug of the legal status of the problem.

Analysis: At present, the "direct contact with packaging material and container management practices", "General Assessment", National Medical Packaging Medical Packaging standards were not on the contents of the package to be provided for identification, but by the enterprise its own, is a leading packaging and labeling confusion, can not play a direct role in the important factor.

Question 2: Composite aluminum cover quality control is difficult to grasp

Use the terminal as a Medical Packaging, part of the pharmaceutical companies and medical institutions Preparation Medical Packaging is not enough room inspection capability, quality control of purchased Medical Packaging depends on the supplier's compliance inspection report. The pharmaceutical formulation of oral liquid aluminum from the internal control standards cover the general appearance of only aluminum cover, specifications, size, microbial limit the number of projects with limited provisions, without the inner stopper of the test items content. According to the requirements of GMP, pharmaceutical companies before buying aluminum cover, from the supplier to the aluminum cover and the registration certificate within the plug of Medical Packaging and other related qualification, but each purchase is equipped with an aluminum cover is a legitimate, qualified medical stopper, often lack Monitor Do not have the inspection capacity. Meanwhile, the aluminum manufacturer in the rubber plug cover purchase, use, management of the factory is more loose, and out of all untested, that the "stopper is not our product anyway," do not need to be responsible for their quality, leading to medical Stopper quality control in production, distribution and use of a vacuum process and blind spots.

Analysis: "Drug Administration Law" and "direct contact with packaging material and container management practices," states: pharmaceutical companies and medical institutions that prepare national standards may not be used with the inconsistent Medical Packaging. The use of unqualified Medical Packaging, and Food Drug regulatory department shall order to stop the use and impose more than 30,000 yuan to 10,000 yuan fine, Medical Packaging has produced or imported by the Food Drug Administration supervision of treatment. The use of unqualified Medical Packaging, and food and drug supervision and administration department shall order to stop using, and impose a 10,000 yuan fine of not less than 30,000 yuan, packaged drugs Medical Packaging shall immediately withdraw food and drug supervision and management departments by supervision treatment.

However, in practice supervision, and drug sector compliance with "statutory standard", whether "unqualified" lack of technical support and determine the appropriate basis. The new National Drug packaging container (material) standard promulgated after it had been issued "Medical Packaging Slip" does not require changes to the oversight difficult. In particular, lined with rubber plugs for a similar compound oral liquid aluminum cover Medical Packaging, the lack of applicable statutory standards. In addition, the current Medical Packaging supervision of testing coverage is not enough, "direct contact with packaging material and container management practices" in the provisions of national and provincial departments of Medical Packaging Drug Administration the production, use random inspection organization. In the absence of supervision and testing authority, primary regulators could not be carried out this work. Sometimes triggered by Medical Packaging failed drug quality issues (such as excessive moisture, jars, etc.) are often produced by pharmaceutical companies "pay" to their Medical Packaging companies improve product quality, lack of initiative and testing capabilities of power and sense of urgency .

by: gaga

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