GMP regulations on pharmaceutical packaging

In modern pharmaceutical production, packaging is a very important part of the production process. In developed countries in the world, the packaging of medicines is relatively strict. The United States first issued GMP regulations, one of the requirements of the regulations is to prevent contamination and confusion. It is stipulated that the packaging of drugs should meet the following requirements: ① Prevent the containers and plugs that directly contact the drug from bringing debris and microorganisms; ② Prevent cross-contamination (mixing of other drug dusts) during the filling and sub-packaging process; ③ Prevent packaging operations Mark confusion occurs; ④ Prevent marking errors (such as printing, printing errors); ⑤ Labels and manuals and other marking materials should be strengthened; ⑥ Packaging finished products need to be inspected; ⑦ All packaging processes should be recorded. GMP regulations are well managed, have been adopted by many countries and are becoming more common. Japan attaches great importance to packaging, and the 'Japanese Pharmaceutical Affairs Law' clearly stipulates the meaning of packaging terms such as drug packaging containers, direct contact containers, packaging materials, inner bags, outer containers, outer packaging materials, additional instructions, and seals. Articles 31-35 of the General Regulations of Japan (Pharmaceutical Prescriptions) are also about matters related to drug packaging. In order to promote the development of international standardization and facilitate international exchanges, the International Organization for Standardization (ISO) 122 Packaging Technology Committee CISO/T (122) formulated dozens of packaging standards. At present, many countries in the world are actively adopting international packaging. China is also actively adopting international packaging in line with relevant national regulations and policies in line with relevant national regulations and policies, focusing on economic benefits, advanced technology, economic rationality, safety and reliability. standards to promote the development of China's packaging industry and improve pharmaceutical packaging.