The State Administration of Pharmaceutical Affairs according to need can be entrusted to the China Pharmaceutical Equipment Industry Association to undertake some of the tasks of pharmaceutical machinery industry management, business by the State Administration of Pharmaceutical Affairs guidance. Article IV of the National Pharmaceutical Machinery Review Committee is appointed by the State Administration of Pharmaceutical Research, design, production, use, management and other aspects of the third-party review of the organization, to assist the State Administration of Pharmaceuticals on the domestic, imported pharmaceutical machinery review and assessment, business by the State Administration of Pharmaceuticals leadership. Chapter II Management of manufacturing enterprises Article V pharmaceutical machinery manufacturers must have the following conditions:
(a) personnel
1, the director must have organizational leadership, familiar with the production of products and technology business, product quality, safety, environmental protection is fully responsible for. Responsible for production, technology, deputy factory director and chief engineer must have a college (or equivalent) and above, and have intermediate and above technical titles, production, technology, quality management experience and organizational capacity.
2, the head of the enterprise quality management department should have intermediate and above technical title, adhere to the principle, familiar with the business.
The inspector should have a high school (or equivalent) and above, after professional training, with a certificate. Full-time inspectors in the enterprise should be more than 5% of the total number of production workers.
Quality management and production management shall not be responsible for each other, and shall not be served by non-staff.
3, the enterprise technical management department must have intermediate technical titles and above, with a certain amount of practical work experience.
The number of engineers and technicians should be more than 10% of the total number of employees. Sales, supplies and other departments should be equipped with specialized technical personnel.
4, the enterprise production workers should have junior high school and above, and by the enterprise professional training, assessment and qualification on duty.
(B) plant, equipment, facilities
1, should have and product production capacity of the plant area and space, and according to the process flow of reasonable layout, with the corresponding storage area.
2, there should be able to meet the requirements of the process equipment, and reasonable layout, easy to operate and maintain.
3, the production of pollution equipment should be in line with the environmental requirements of the protective measures; three waste management must meet the environmental requirements.
4, should have with the production of products suitable for testing and measuring instruments and test equipment. Article VI of the enterprise management
(a) the production of products must be made according to national standards, industry standards or enterprise standards for the development of products and post-processing procedures and operating procedures and other technical documents.
(b) the product design documents, process documents have a strict system of scrutiny and file management system.
(c) modify the design documents, process documents must have an approval system, text records, information must be archived.
(d) in accordance with the design documents, process documentation requirements for the development of product testing procedures.
(E) should establish equipment file management, maintenance and regular maintenance system.
(F) production and inspection of measuring instruments, meters should be used, maintenance and regular calibration system.
(VII) raw and auxiliary materials, semi-finished products should be classified according to different materials, varieties, specifications, storage, should be clearly marked, and has a certificate of conformity. The main raw materials certificate of conformity should be established information files.
(viii) outsourcing processing, purchasing components, raw and auxiliary materials procurement should develop strict management and acceptance system.
(ix) conscientiously implement the "People's Republic of China *** and the State Statistics Law", establish and improve the production management of the economic and technical indicators of basic data statistics. Entrusted by the State Administration of Pharmaceutical Industry, China Pharmaceutical Equipment Industry Association to undertake the statistical work of the pharmaceutical machinery industry, the production enterprises should be on time, according to the requirements of the China Pharmaceutical Equipment Industry Association to submit "pharmaceutical machinery industry 01￣03 statement".
(J) to establish and improve the quality system.
(k) In order to continuously improve the quality of products, the establishment of internal and external quality information feedback system. Article VII of the State Administration of Pharmaceutical Machinery key products for the implementation of "production license" system. Implementation of the "production license" of the product catalog by the State Administration of Pharmaceutical Affairs announced in stages. Article VIII prohibits the production of the following products:
(1) products eliminated by state order, products without product standards, products without appraisal;
(2) the use of poor-quality main and auxiliary materials and poor-quality purchased parts of the product;
(3) lower than the product standards for products below the specified performance indicators;
(4) no product qualification certificates, instruction manuals, nameplate Products;
(E) fraudulent use of other people's factory name, name and logo, international honor marks, certification marks, patents, production licenses and other products.