Sinomach Pharma Industry Validation-chinese and english rev1.pptVIP

Pharmaceutical IndustryValidation 制药工业的验证 Presented by - Jonathan Woodburn, Vice President, Compliance Validation Good Manufacturing Practice 良好生产规范 (GMP) Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation. GMP 是质量保证的一部分，它保证产品按照其使用要求及管理部门规范，以适当的质量标准持续稳定地生产。 Ten Commandments of GMP GMP十诫 Definition - Pharmaceutical Process Validation定义- 制药工艺验证 FDA Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. 验证是指通过提供文件记录证明，切实保证某一特定工艺持续生产出符合其预定规格及质量特性的产品。 Definition - Pharmaceutical Process Validation定义- 验证 Simply stated, Validation is proofthat ……..简而言之，验证将证明 A Process Works! 某一过程可正常进行 Process Validation - Why Validate?为何验证？ The need for Validation 验证的必要性 Regulatory requirement (cGMP) 规范的要求 (cGMP) Improved product quality 改进产品质量 A Quality Assurance approach 质量保证体系的环节 Efficient manufacturing processes 确认生产过程有效性 Good business practice 良好的行业规范 Process Validation - Why Validate?为何验证？ 15 % of production cost is waste. 有15 %的产品为废品 Losses in manufacturing process are unavoidable ?? 生产过程中的损失是不可避免的 Waste is created because potential sources of trouble are unknown. 因潜在问题原因不明，废品因而产生 Adequate validation prevents unpleasant and expensive surprises arising from the process. 恰当的验证可避免过程中不愉快及昂贵的意外产生 Process Validation - Why Validate?为何验证？ Validation and cGMPs验证与cGMP Process validation is required, in both general and specific terms, by the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211 根据有关制剂的现行GMP规范及21 CFR第210和211部分的要求，过程验证在原则上和具体实践中都是必须的 WHO Good manufacturing practices for pharmaceutical products define validation and provide details of process validation 世界卫