subject: Pharmaceutical Packaging Substantial Development Package With The Increasingly Strict - [print this page] China Pharmaceutical Packaging Association, vice president of dam safety that: As the importance of gradually pharmaceutical packaging pharmaceutical industry authorities and business knowledge, combined with the pharmaceutical industry, and the continuous development of science and technology, China's pharmaceutical packaging has changed dramatically, especially Since reform and opening, it is progressing towards a scientific and modern, to catch up with international advanced level.
Basically meet the needs of seven major types of packaging
Founding of New China, the very few domestic pharmaceutical companies are the main agents, production is lagging behind, which are all manual pharmaceutical packaging, packaging materials are used by a number of small factories, small workshops with the most simple and primitive method of production. 50 late 20th century, and gradually get rid of manual packaging chemicals, packaging and pharmaceutical preparations began around two main themes of glass production developed many simple and practical mechanical equipment for the pharmaceutical packaging to provide the most basic packaging materials.
To 1980, a group of medical glass, rubber plugs, hard shell capsules, pharmaceutical packaging machinery manufacturers rise to the development needs of China's pharmaceutical industry provides a large amount of packaging materials and packaging equipment. But as a whole, the level of product quality and technology from international standards and so very far. To gradually change the backward state, in 1983, the State Administration of Traditional Chinese Medicine to develop a new development plan, to promote new technologies, new processes, new materials, and gradually change our drug packaging materials, container structure as a key, out of, or the phasing out of natural rubber and other behind the products and packaging. Focus on the introduction of foreign advanced equipment and self-developed advanced medical glass machinery, hard capsule shell production equipment, the development of easily bending neck ampoule, rubber plugs, plastic bottles, composite materials, mechanisms and other new hard capsule shell packaging materials and containers.
"Eighth Five-Year" period, in order to speed up the medicinal packaging materials, containers replacement, eliminating the backward packaging materials, containers, new construction, expansion and transformation of a group of hard shell capsule, pharmaceutical plastic bottles, aluminum foil, and butyl medicinal rubber plugs and other production enterprises, so that our new drug packaging materials, containers has been greatly increased production capacity, technical level also has been enhanced.
From April 1, 1992, the former State Pharmaceutical Administration of the production of direct contact with the packaging material, container production and business enterprises to implement licensing system. Have been able to produce glass containers, plastic containers, metal containers, ceramic containers, composite materials, hard gelatin capsule, and cover, plugs, gaskets, sealing diaphragm 43 in seven major product categories, production, varieties can basically meet the pharmaceutical industry needs.
Perfect setting standards and regulations: from healthy institutions to strictly control
China Pharmaceutical Packaging Association Secretary-General Choi Hong Jieshao, pharmaceutical packaging industry, albeit complementary medicine, but because of its direct impact on the quality and use of safe drugs, national drug regulatory department has attached great importance. State Administration of Traditional Chinese Medicine was set up after the establishment of packaging technology, is responsible for development planning and pharmaceutical packaging industry management. At the same time in order to enhance the exchange of information pharmaceutical packaging technology, the initiative by the State Pharmaceutical Administration and approval, in June 1980 established the "National Pharmaceutical Packaging Technology Center Point", that today's "China Pharmaceutical Packaging Association" predecessor.
1980, the State Administration of Traditional Chinese Medicine has developed "medical packaging Regulations" (draft), and in July 1981 formally implemented in the country, for the management of pharmaceutical packaging gradually opened legal precedent. Meanwhile, the State Pharmaceutical Administration in 1970 began to develop drug packaging materials, containers, product standards, issued in 1998 ampoules, glass bottles, glass infusion bottle, Chinese herbal medicines and other corrugated than 20 state standards and industry standards.
1998, the State Drug Administration (SDA) form. To further enhance the packaging, the State Drug Administration in April 2000 Council issued Order No. 21 "drug packaging materials, container management practices" (temporary), on the drug packaging materials implement the registration management. December 2001, the NPC revised the "Drug Administration Law of the People's Republic."
2002 9 months, the State Council promulgated the "Regulations for the Implementation of the PRC Drug Administration Law", establishes the legal basis for the management of pharmaceutical packaging. Which clearly stipulates that direct contact with the packaging materials and containers must meet the medical requirements, comply with safety standards to protect human health by the drug regulatory agency in conjunction with the approval of drugs for approval. Drug manufacturers may not
direct contact with the use of unauthorized drugs, packaging materials and containers, or in a pseudo-crystal punished.
