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Notice of the state food and drug administration on strengthening the supervision and administration of pharmaceutical glass packaging injections
The food and drug administration of the provinces, autonomous regions, municipalities directly under the central government and Xinjiang production and construction corps ( drug administration ):
According to the information of drug supervision and inspection, part of the injection of Insect Growth Regulator drugs and the selected medicinal glass has interaction, affecting the quality of medicine, causing a certain safety hazard. In order to ensure product quality and ensure public drug safety, the notice on matters related to strengthening drug supervision and administration of pharmaceutical glass packaging is as follows:
1. pharmaceutical production enterprises must be responsible for the quality of products produced. The compatibility of injection products and used pharmaceutical glass should comply with the requirements of relevant technical guidelines such as the guiding principles on drug packaging materials and drug compatibility ( ybb00142002 ) published by the national food and drug administration. If not, the use of the drug must be stopped immediately, and the study of standardization; According to the results of the study, the appropriate medical packaging materials, and timely to make the application of the change. Prevent the improper use of improper medical packaging materials caused by drug quality problem.
2. the pharmaceutical production enterprise shall select the packaging materials that can ensure the quality of the drug according to the characteristics of the drug. For biological products, piansuanpianjian and ph injection, the water resistance at 121 ℃ should be selected as grade 1 and the water resistance of inner surface is HC1 grade of medical glass or other suitable packaging materials. For the injection of Insect Growth Regulator drug packaging materials to meet the requirements of the water demand for pharmaceutical glass to meet the above requirements for pharmaceutical glass, pharmaceutical production enterprises can complete the relevant research reports in the province ( region, city ) food and drug regulatory approval. For the change of pharmaceutical glass packaging manufacturers, the pharmaceutical production enterprises may, after the completion of the compatibility of drugs and pharmaceutical glass packaging, report to the food and drug administration department of the location province ( district and city ) for record.
Iii. the pharmaceutical production enterprise shall conduct on-site quality audit and retrospective analysis of pharmaceutical glass production enterprises on a regular basis in accordance with the requirements of good manufacturing practice ( 2010 revision ), and conclude quality agreement with it to establish supplier quality file and inspect regularly the compatibility of medicinal glass and medicine. It is found that the compatibility of pharmaceutical and pharmaceutical glass should be Again when the raw materials, prescriptions and processes are changed. After purchase of each batch of medicinal glass, it shall be inspected according to the standard, and can be approved by the national standard.
Iv. the food and drug administration at all levels shall incorporate the supervision and inspection and supervision of pharmaceutical packaging materials into the work plan, and strengthen the supervision of pharmaceutical packaging materials. In order to focus on the enterprises found problems in the past supervision and inspection, increase the frequency and strength of supervision and inspection, and not meet the standards of the product quality, and deal with it according to law.
This notice shall be executed from the date of promulgation. The food and drug administration departments at all levels shall strengthen publicity and guidance, increase the daily supervision and management of pharmaceutical glass and injection enterprises, urge drug manufacturers to strictly implement the relevant provisions, implement responsibilities, eliminate safety hazards and ensure product quality.
Office of the national food and drug administration
8 November 2012