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What is drug GMP?
"GMP" is an abbreviation of Good Manufacturing Practice in English. Chinese means "good practice" or "good manufacturing standard". It is a kind of autonomy management system that pays particular attention to the implementation of product quality and hygiene safety in the production process. It is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires companies to meet the requirements of sanitary quality according to relevant national laws and regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc., to form a set of operational The operating rules help companies to improve the corporate health environment, timely find problems in the production process, and improve them.
GMP (Good Manufacturing Practice) refers to the quality of personnel and production operators who are responsible for guiding the quality control of pharmaceutical production to production plants, facilities, construction, equipment, storage, production processes, quality management, process hygiene, packaging materials and labels. Until the end of the storage and sales of a complete set of drugs to ensure the quality of the management system. GMP aims to ensure the production of good medicines. It is the basic criterion for the production and management of medicines, and is also the basis for the construction, renovation, and expansion of pharmaceutical companies.
With the continuous deepening of the GMP certification work, the quality of production management in the pharmaceutical industry in China has made considerable progress, but the old version (1998 version) of GMP can no longer well regulate and promote the development of the pharmaceutical industry, GMP should not be static, It should be dynamic, so as to adapt to the new situation and new development of the pharmaceutical industry in China, and to conduct stricter and more comprehensive supervision and administration of pharmaceuticals. Therefore, the Ministry of Health implemented the revised 2010 GMP on March 1, 2011.
Comparison and analysis of the new version of GMP and the old version I. Improved hardware requirements Sterile preparations have been greatly improved in hardware, with more emphasis on sterility and purification requirements in the production process; on software management, management of personnel, handling of deviations, documents Management, quality control and quality assurance, quality review, etc. have greatly improved. The 2010 version has a great impact on high-risk aseptic manufacturers. Due to the increased cleanliness level, the investment in plant construction and equipment will be very large.
Second, to strengthen the management requirements 1, to improve the requirements of personnel For example, the person in charge of production management and quality management requirements from the old college level to more than college, required to have relevant management experience and clear The responsibilities of key personnel. In addition, the newly revised pharmaceutical GMP first put forward the concept of quality attorneys, and incorporated the quality attorneys into the key personnel of pharmaceutical production companies.
2. It is clearly required that enterprises establish a new edition of the drug quality management system to put a separate chapter on quality management. Enterprises must establish a comprehensive quality assurance system. The new GMP has improved quality management to a certain level. The entire pharmaceutical company, from the highest leadership to the employees, must be responsible for quality and formulate its own management plan. The new version of GMP for pharmaceuticals has increased the requirements for establishing a quality management system in the “General Provisions†to ensure the effective implementation of GMP.
3. Detailed requirements on document management such as operation procedures and production records. In terms of document management, the new version of GMP greatly enhances the requirements for document management, increases the scope of document management, and includes all relevant product quality issues. Quality standards, production prescriptions, and process specifications, records, reports, etc. all cover the scope of GMP document management. With the widespread use of computerized program control systems, the new version of GMP has also increased the content of electronic records management. The application of information technology makes GMP keep up with the development of the times, but it also increases the cost of the company.
Thirdly, a series of new systems have been set up around risk management. Quality risk management is a brand-new idea promoted and implemented by the US FDA and the European Union. The new version of pharmaceutical GMP introduces the concept of quality risk management and adds a series of new systems accordingly.
Compared with the old version, the new version of drug GMP has greatly improved, laying a good foundation for the future of China's pharmaceutical industry in line with international standards. However, the old version of GMP still has some deficiencies. One point is that the new version does not require intermediate products and finished products. Detailed specifications, I hope that the revised version can be more perfect.
Fourthly, it emphasized that the process of effectively linking up the quality management of pharmaceuticals with other regulatory aspects such as drug registration and drug recall is the implementation and reflection of the registration approval requirements. The new version of drug GMP emphasizes the consistency of production requirements and registration approval requirements in several chapters. For example, enterprises must carry out production according to the approved prescriptions and processes, carry out inspections in accordance with the registered quality standards and inspection methods, and adopt the quality standards of registered raw materials and packaging materials that are in direct contact with the drugs, and their sources must also be registered. The approval is consistent, and only those medicines that meet the requirements for registration and approval can be released for sale.
The new version of drug GMP also pays attention to the link with the "Drug Recall Management Regulations" and stipulates that enterprises should recall the listed drugs with potential safety hazards, and at the same time, detail the management regulations for recalls, require companies to establish a product recall system, and designate special personnel to implement recalls. Coordinate relevant work, develop written recall procedures, etc.
Recently, the National Food and Drug Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology and the Ministry of Health officially issued the "Notice on Accelerating the Implementation of Newly Revised Drug Manufacturing Quality Management Standards and Promoting Upgrading of the Pharmaceutical Industry." Under the requirement of adhering to standards and reducing time, four ministries and commissions launched incentives in the areas of mergers and acquisitions, certification inspections, review and approval, commissioned production, price adjustments, tender procurement, and technological transformation to encourage and guide drug production. The company quickly reached the newly revised pharmaceutical GMP.