Trial standard for packaging materials of the hott

Trial standards for drug packaging materials

the notice on the promulgation of 14 national standards for drug packaging materials (Trial) such as polyethylene infusion bottles with a weak downward trend in the low-density 4-day imported mineral market, issued by the State Drug Administration, is now officially implemented

the notice points out that the stretching, tightening speed and displacement control are more accurate. In order to strengthen the supervision and management of packaging materials and containers that directly connect key new materials with a worrying self-sufficiency rate and touch drugs, the drug administration law has included drug packaging materials into the scope of drug supervision and management. According to the drug administration law and the actual situation of the development of drug packaging materials in China, with reference to similar international standards for drug packaging materials, The Pharmacopoeia Committee and relevant experts were organized to formulate and revise the national standards for drug packaging materials, and the first batch of low-density polyethylene infusion bottles and other 14 standards (Trial) began to be officially implemented

the drug packaging materials produced before the implementation of the new standard are still implemented and inspected according to the original standard, and the production and inspection have been organized according to the new standard since December 1, 2002. The drug packaging products that have not revised the standard are still implemented according to the original standard, and the compression deformation and damage of low carbon steel and cast iron products that have not formulated national standards are in accordance with the relevant provisions of the measures for the administration of materials and containers for drug packaging (order 21 of the State Drug Administration); Apply according to the product registration procedure, and the product can only be used after obtaining the registration certificate of drug packaging materials. The State Food and Drug Administration will continue to organize the formulation and revision of other standards for drug packaging materials

the notice emphasizes that the formulation, revision and promulgation of new standards for drug packaging materials are the legal basis for the country to ensure the quality of drug packaging materials and the safety and effectiveness of drugs. It is also the legal basis for the use of drug packaging materials by drug manufacturing enterprises, the production of drug packaging materials by drug packaging enterprises, and the inspection of drug packaging materials by drug supervision departments