欧盟GMP附录1 无菌产品生产--中英版.pdfVIP

EU GMP Annex 1 : Manufacture of Sterile Products DRAFT Annex 1 : Manufacture of Sterile Products 附录 1 ：无菌药品生产 Document map 文件导览 Section Number General overview 章节编号 概览 1. Scope Includes additional areas (other than sterile products) where the general principles of the annex can be applied. 范围 包括了附录通则适用的其它领域（无菌药品以外） 2. Principle General principles as applied to the manufacture of sterile products. 通则 无菌药品生产适用通则 3. Pharmaceutical Quality Highlights the specific requirements of the PQS when applied to sterile System (PQS) products. 药品质量体系（PQS） 突出了无菌药品 PQS 的特定要求 4. Premises General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of Barrier Technology. 设施 设施设计方面的特殊需要通用指南，以及设施确认指南，包括隔离技术的 应用。 5. Equipment General guidance on the design and operation of equipment. 设备 设备设计和运行方面的通用指南。 6. Utilities Guidance with regards to the special requirements of utilities such as water, gas and vacuum. 公用设施 公用设备方面的特殊要求指南，如水、气体和真空。 7. Personnel Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel. 人员 特殊培训、知识和技能方面的要求指南。亦提供了人员确认方面的指南。 8. Production and specific Discusses the approaches to be taken with regards to aseptic and terminal technologies steri