药包材变更管理的分析与探讨

Analysis and Discussion on Change Management of Pharmaceutical Packaging Materials

目的:通过汇总分析美国对药包材变更的管理法规和管理方式,为我国实施关联审评审批后对药包材变更管理提供借鉴,从而保证药品在整个生命周期内的安全、有效和质量可控。方法:从法规和技术层面分析美国FDA对制药企业以及药包材企业的变更监管,探讨其优势和存在的问题,对比中国与美国行业的特点。结果:中国与美国在监管理念和法规上日渐趋同,但是国内药包材企业与美国在规模和管理上还存在较大差异。结论:药包材变更是药品生命周期维护的组成部分,行业监管机构需要出具相应的变更技术指导原则以及相应的法规路径作为研发人员对变更评估的重要参考依据。

Objective: To summarize and analyze management regulations and methods for the change of pharmaceutical packaging materials in the United States and to provide references for the change management of pharmaceutical packaging materials after the implementation of the bounded review and approval in China so as to ensure drug safety, effectiveness and quality throughout drugs’ life cycle. Methods: The change management of pharmaceutical companies and pharmaceutical packaging material companies made by the US FDA were analyzed from the regulatory and technical aspects. The advantages and existing problems were discussed and the characteristics of the industries of China and US were compared. Results: China and US have gradually reached agreement in terms of regulatory concepts and regulations, but there are large differences in scales and management between pharmaceutical packaging material companies in two countries. Conclusion: Changes of pharmaceutical packaging materials are an integral part of the maintenance for drugs’ life cycle. Regulatory agencies need to issue corresponding technical guidelines for the change and regulatory paths as important references for R&D people to assess change control.