Zhongbang consulting sorted out the following knowledge points for you:

  1. Pharmaceutical packaging materials: materials and containers for pharmaceutical packaging. The Drug Law stipulates that the packaging materials and containers that come into direct contact with drugs must meet the requirements for medicinal use, meet the standards for protecting human health and safety, and be examined and approved by the drug regulatory department when approving drugs. Do not use unapproved packaging materials and containers that come into direct contact with the drug.

  2. Divided into three categories:

  Class I pharmaceutical packaging materials: pharmaceutical packaging materials and containers directly in contact with the drug and directly used;

  Class II pharmaceutical packaging materials: pharmaceutical packaging materials and containers that are in direct contact with drugs and need to be sterilized after cleaning;

  Class III pharmaceutical packaging materials: other than class I and Class II pharmaceutical packaging materials that may directly affect the quality of drugs | educational | educational network collection, container.

  3. Product registration system.

  1) Drug packaging materials registration certificate: The production of Class I drug packaging materials SFDA approval registration, production of Class II, III drug packaging materials Provincial drug Administration approval registration. The validity period of the Registration Certificate of Pharmaceutical Packaging Materials is five years, and the application for renewal is six months before the expiration.

  2) Application for registration:

  (1) Business license;

  (2) Meet the needs and development direction of China's drug packaging, and products that are eliminated by explicit orders or deadlines are not registered.

  (3) reasonable process, equipment, cleanliness requirements \ inspection equipment, personnel, management system, etc.;

  (4) The production of Class I drug packaging materials, the same cleanliness conditions as the production of packaged drugs, and the designated testing institution to check qualified.