药包材生产申请资料的探讨

目的 帮助和指导国内药包材生产企业更好地准备申请产品的注册申报资料,满足技术审评的基本要求;同时,有助于审评机构进行科学规范的审评,提高审评工作的质量和效率.方法 对目前药包材生产申请所需提交的12项资料,重点从3批申报产品的质量检验报告书;申报产品生产、销售、应用情况综述;产品配方;产品的生产工艺及主要生产、检验设备说明;申报产品的质量标准;3批申报产品的企业自检报告书以及与采用申报产品包装的药品相容性研究资料等7个方面,提出了细化注册申报资料的具体内容.结果与结论 结合药包材生产现状,对药包材企业生产申请所需提交的资料进行细化和规范化,有利于药包材生产申请工作的顺利开展.

Discussion on Application Materials for Drug Package Production

Objective To better prepare the materials needed to apply for drug package production registration and fulfill basic requirements of technical evaluation, and meanwhile to enhance scientific and standard evaluation of review agencies and improve quality and efficiency of evaluation work. Methods For the 12 materials currently required for application of drug package production, the article proposed specific contents to refine registration and application materials, with focuses on the following 7 aspects, quality test report for 3 batches of products for application, information on production, sale and utilization, product formulation, production techniques, instruction on main production and test equipment, quality standard, enterprise self-test report for 3 batches of products for application as well as materials of studies on drug compatibility for the product package. Results and Conclusion Besed on the current status of drug package production, some suggestions on how to standardize and refine the application materials are very constructive for a smooth process of drug package registration.