DMR要求.pptVIP

DMR 对于每中设备的DMR应包括或参照: 设备的规范,包括适当的图纸,成分,公式,组件的规范和软件规范 生产过程规范包括, 适当的设备规范,生产方法,生产程序和生产环境规范 质量包装程序和规范包括,接受标准和使用的质量保证设备 保证和标签规范,包括使用的方法和过程 安装,维护和服务程序和方法 DMR 1.0 Device Master Record Index The device master record Index is a table of contents which is used for convenience. It may be known as a: Device Master Record Index Documentation or Device Master Record Unit; Documentation Plan; Product Tree; Documentation Index; Product Structure; or Bill of Materials (if it also lists the device master record documents). 2.0 Device Specifications (Device specifications are described in the chapter text.) DMR 3.0 Manufacturing Information 3.1 Index (Optional. See 1.0 above for total table of contents.) 3.2 Formulation or top assembly drawing 3.3 List of components 1. List of ingredients (including grade or type) 2. Bill of materials (i.e., component list usually arranged by subassembly or other sub product level or by process steps) 3. Formula 3.4 Procurement documentation 1. Specifications 2. Drawings 3. Certificate of compliance requirements 4. Supplier Assessment procedures DMR 3.5 Device documentation 1. Fabrication drawings 2. Surface finish procedures 3. Subassembly drawings 4. Wiring and piping diagrams 5. Assembly procedures 6. Assembly drawings 7. Reference documentation a. Wiring and piping schematics b. Test specifications 8. Sub batch procedures 9. Blending or mixing procedures 10. Solution procedures 11. Final formulation procedures 12. Software packages DMR 3.6 Precautions and special notations 1. Apparel 2. Cleaning 3. Storage conditions 4. Filling, mixing conditions 5. Hazards and safety precautions DMR 3.7 Equipment, lines, and procedures 1. Process lines 2. Assembly lines 3. Vessels 4. Mixers, tools 5. Molds 6. Machine maintenance procedures 7. Calibration procedures 8. Setup procedures 9. Operating procedures 10. Process flow charts DMR 3.8 Sterilization procedures 1. Procedures for ethylene oxide, radiation, filtration, steam, etc. 2. Handling