1、需要补充:料液稳定性，过滤器完整性测试（若过滤器重复使用，需提供风险评估及额外验证数据）。

2、仅需提交英文版：CEP申请以英文材料为准，无需提供中文方案/报告 ，但国内GMP检查需中文签批版。

关于申报资料要求可以参见EDQM CEP Guidance for electronic submissions for Certificates of Suitability (CEP) applications 202107

The applicants are expected to provide relevant information about the sterile aspects of the manufacturing process in sections 3.2.S.2.2 and 3.2.S.2.5 as applicable.

•         Justification for method of sterilisation

•         Manufacturing areas

•         Summary of manufacturing process related to sterile filtration/aseptic processing

•         Information on filters used

•         Validation of the filters used

•         Sterilisation of filters and processing equipment

•         Pre-filtration Bioburden

•         Re-use of filters

•         Aseptic processing

•         Process Simulation / Validation

•         Sterilisation of Packaging

•         Re-test Period

详见：Content of the dossier for sterile substances, PA_PH_CEP (23) 54, November 2024.pdf