Order No. 14 of the State Medical Administration of January 12, 1996) Chapter I General Provisions Article 1 is to implement the 'Product Quality Law of the People's Republic of ChinaIn accordance with the GB/T19000-ISO9000 'Quality Management and Quality Assurance' series of standards to improve the quality and technical level of
pharmaceutical machinery products, and promote the development of the pharmaceutical machinery industry, these measures are hereby formulated. Article 2 The State Medical Administration is responsible for the industry management and supervision of pharmaceutical machinery nationwide. The pharmaceutical management departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the industry management and supervision of pharmaceutical machinery in their respective regions. Article 3 All enterprises and institutions engaged in the production, operation, scientific research, and quality inspection of pharmaceutical machinery must abide by these Measures. Article 4 The state encourages the scientific research of pharmaceutical machinery and the promotion of advanced technology, and encourages the production, sale and use of quality-certified pharmaceutical machinery. Chapter II Management of Manufacturing Enterprises Article 5 Pharmaceutical machinery manufacturing enterprises must meet the following requirements: (1) Have management personnel, engineering technicians and skilled workers suitable for the pharmaceutical machinery they produce; Applicable plants, facilities, equipment and sanitary conditions; (3) Have production technology management procedures that are compatible with the pharmaceutical machinery produced; (4) Have a quality system compatible with the production of pharmaceutical machinery; (5) Comply with the national Relevant requirements and regulations for machinery production management. Article 6 An enterprise that produces pharmaceutical machinery must obtain a 'business license' issued by the administrative department for industry and commerce at or above the county level. Article 7 The catalog of pharmaceutical machinery products subject to an industrial product production license shall be formulated by the State Medical Administration in accordance with the plan of the State Technical Supervision Bureau. For all pharmaceutical machinery that has a production license, an enterprise must obtain a 'production license' before it can engage in production. Article 8 The production of the following products is prohibited: (1) Products that are explicitly eliminated by the state; (2) Counterfeit, counterfeit, counterfeit and inferior products. Article 9 The State implements industry management of pharmaceutical machinery, and encourages enterprises in the military, machinery, and electronics sectors to make full use of existing foundations and talents and technological advantages to develop new pharmaceutical machinery products, carry out professional collaboration, and develop economies of scale. The state does not fix point production of pharmaceutical machinery. Chapter Three: Management of Operating Enterprises Article 10 Pharmaceutical machinery operating enterprises must obtain the 'Business License' issued by the industrial and commercial administrative department at or above the county level before they can conduct business operations. Article 11 It is forbidden to operate the following products: (1) Products produced by enterprises that have not obtained the 'Production License' and subject to the 'Production License'; (2) Products with incomplete product qualification certificates, product nameplates and necessary technical documents Products; (3) Products that are explicitly eliminated by the state; (4) Counterfeit, counterfeit, counterfeit and inferior products. Article 12 Pharmaceutical machinery business enterprises must strictly abide by the 'People's Republic of China Anti-Unfair Competition Law' and 'Pharmaceutical Industry Regulations on Anti-Unfair Competition' and other relevant laws and regulations, and actively recommend famous and high-quality pharmaceutical machinery products to users. Article 13 The State Administration of Medicine sponsors the 'National Pharmaceutical Machinery Expo (Exhibition Fair)'. Without the approval of the State Medical Administration, no unit may hold a national pharmaceutical machinery exposition (trade fair). Chapter 4 New Product Management Article 14 The new product of pharmaceutical machinery refers to the first time that the pharmaceutical machinery product adopts new technical principles, new design concepts or is more obvious than the old product in terms of structure, material, process, etc. or one of them. Improvement, which significantly improves the performance of pharmaceutical machinery products or expands the use of functions, and has a certain effect on improving economic benefits. Article 15 The scientific research trial-manufacture, plan, project application, review and project organization and implementation of new pharmaceutical machinery products, and the appraisal of the results shall be in accordance with the 'Administrative Measures for the Medical Scientific Research Plan of the State Medical Administration' (for trial implementation) and the 'Appraisal of Scientific and Technological Achievements of the State Medical Administration' Management Measures (for trial implementation) and relevant national regulations. Article 16 The Pharmaceutical Machinery Testing Center of the State Medical Administration is responsible for performance testing, routine testing and business guidance of new pharmaceutical machinery products. Article 17 The new product prototype of pharmaceutical machinery must undergo appraisal and acceptance after production assessment. The appraisal and acceptance of new products of pharmaceutical machinery can be combined with the appraisal of the prototype and the appraisal of the production. New products that have not been authenticated are not allowed to be officially produced and sold. Article 18 New pharmaceutical machinery products that have been qualified shall be declared as national-level key new product trial-manufacture plans or regional-level key new product trial-manufacture plans in accordance with relevant regulations, and enjoy preferential treatment in accordance with current national regulations. Chapter 5: Product Standards and Quality Management Article 19 The State Medical Administration is responsible for the standardization management of the pharmaceutical machinery industry. Article 20 The State Medical Administration shall be responsible for organizing the drafting of the national standards for pharmaceutical machinery, and shall be submitted to the State Technical Supervision Bureau for approval and promulgation. The pharmaceutical machinery industry standards are reviewed and promulgated by the State Medical Administration.
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