Certificates for Pharmaceutical Packaging

There are two types fo certificates for pharmaceutical packaging. One is for the nature of materials. The other one if based on quality management systems.

Certificates for the nature of materials. A manufacturer of packaging should provide the basic certificates to state the materials are food safety. Further stability test between the plastic materials and the medicines should be completed by the manufactuers of finished medicines. Because plastic raw materials’ chemical character doesn’t change after molding process, the test based on raw materials or based on the plastic components are both valid. FDA standards were listed in the section Materials Food Safety Standard. Eu also has EC standard. Regulation (EC) No 1935/2004, is EU’s framework regulation and sets out general requirements for all food contact materials (FCMs).

Certificates based on quality management systems. The most basic certificates are ISO 9001, but it is too gereral. The special certificate for packagings is ISO 15378 (GMP for primary pharmaceutical packaging). Devices’ certificates is ISO 13458. Packaging and device are different but the difference is not clear in the registration of in some countries. For different countires, the relating depart has the country-based certificate for pharmaceutical packaging manufacturers. In US, it is DMF (drug master file). In China, it is CFDA registration (China FDA, and now CFDA ‘s name is changed to NMPA, National Medical Products Administration). The country-based certificate may also inclue the evaluation of the nature of materials.