Pharmaceutical Association Plastic Infusion Bottle Packaging Pellet Safety Meeting Minutes

According to the opinion of the drug packaging material registration and evaluation committee, in June this year, the China Pharmaceutical Packaging Association held a symposium on infusion plastic bottle manufacturers and pellet suppliers to study the safety evaluation and migration of raw materials for infusion plastic bottles in the future. To ensure the quality of infusion products and promote the healthy development of the infusion industry. After the meeting, the Association sent a letter suggesting that all relevant companies carry out this work as soon as possible, and provide relevant information in the application for registration and re-registration. Relevant companies unanimously agreed that it is very necessary and urgent to carry out the evaluation on the safety of aggregates. However, it is generally reported that they do not know how to proceed, and it is recommended that relevant departments of the state formulate relevant standards or guidelines. To this end, the Pharmaceutical Packaging Association convened the "Seminar on the Safety of Infusion Plastic Bottle Packaging Granules" on September 15, 2009 to discuss the specific contents and requirements for the evaluation of the safety of pellets.

The leaders from the General Office of the Drug Registration Department of the State Food and Drug Administration and the Drug Registration Office of the Hebei Food and Drug Administration attended the meeting. From the China National Institute for the Control of Pharmaceutical and Biological Products, there were 16 drug packaging material review experts, including pharmaceutical excipients and packaging materials, and other major drug packaging material testing organizations, who attended the meeting.

Director Li Maozhong of the Department of Drug Registration of the State Food and Drug Administration and Yin Liya of the Drug Registration Office of the Food and Drug Administration of Hebei Province unanimously affirmed the importance of this seminar and believed that drug safety concerns the national economy and the people’s livelihood, each time. The “drug hazard” incidents have caused great concern in the whole society. This time through the study of controlling the safety of the infusion plastic packaging materials and pellets to ensure the safety of infusion products is a very important issue. The conference is also held in a timely manner. . Director Li Maozhong also stated that he hopes that through the concerted efforts of drug packaging companies, companies, testing organizations, and other parties, strengthen research, ensure the quality of drug packaging materials and drug safety, and hope to pass through various channels such as the China Inspection Institute and the Association in the future. Hear more opinions and suggestions on the supervision of pharmaceutical packaging.

Experts discussed and studied and agreed that:

First, infusion plastic bottle containers and interfaces, inner cover must be submitted to apply for drug packaging material registration, must submit the composition of the pellets (antioxidants, stabilizers, plasticizers, lubricants, solvents and / or dyes, etc.) and safety research material.

Second, for the pellets and additives used and the ingredients that may be introduced during the production process, the safety evaluation is based on the requirements of the "decision tree" in the GUIDELINE ON PLASTIC IMMEDIATE PACKAGING MATERIALS. Provide information: The general information and specification standards (including the description of the plastic, the CAS number of the chemical abstracts of the compound, the material identification, the character, the identification of the main additive, and the coloring agent) shall be provided for the varieties contained in the relevant pharmacopoeia at home and abroad. For identification and interaction studies (mainly including mobility studies and adsorption studies); for species not included in the national and international pharmacopoeia, in addition to providing general information, specification standards, and interaction studies, additional extraction studies and Toxicological research data.

Third, for the registered and used infusion plastic bottle packaging materials, they should closely monitor the safety of their production and use. At the time of re-registration, the safety conditions during production and use after registration must be submitted, as well as the research data indicated in Article 2.

IV. It is recommended that the drug review center should require drug manufacturers to select the packaging materials and packaging forms when reviewing new drugs or changing the packaging of drugs, and provide compatibility tests for drugs and packaging materials, not just the stability test data. .

5. For infusion products that need to be infused with drugs during clinical use, it is recommended that manufacturers of infusion products carry out relevant research work such as migration and adsorption tests for the drugs that may be added.