制程认可管理与控制方案.ppt

没有一个多功能的团队，就不能识别出过程中的各方面的潜在风险，从而响应地不能设计出完整的测试方案，导致验证不彻底，给日后的批量生产留下后患。 这些成员的设置是根据企业的实际情况而定的，原则就是凡是影响质量的各个方面都有那方面的专职人员参与并给予评估。 当团队组建后就要进行以下步骤： １。如对塑料配方改变的验证，受塑料配方改变的影响的产品特征就是袋身的强度，袋子的对冷／热的耐受性，受此影响的还有就是袋子的封边工艺参数的响应变化从而保证袋子封边的完整性。如要求高温高压灭菌时不爆裂，灭菌后经受２５０公斤挤压７２秒封边不开列泄露。 ２。质量标准：如溶液制剂－－－包括澄明／清度，处方，各成分的浓度，ＰＨ等，包装容器－－－ 自身强度，与药物的兼容性，溶液的流出速率等，甚至产品的外包装等次要的系统，都有其相应的要求，如纸箱，有抗压力的强度，粘合强度，对环境湿度的耐受程度等要求。 说明要求的方法之一就是使用设计输入， 物理要求－－－水蒸气透过率，保证有效期内不会挥发。（保证有效期） 功能要求－－－封边撕开力在某一范围内。（保证包装的完整性和方便使用） 安全要求－－－是否要求无菌，无热原，产品的有效期多长，材料的生物兼容性要求，对工厂及工人的健康安全方面的考虑等。 包装要求－－－必须能经受高温和低温的影响（保证包装的完整性），包装内必须有一说明书等。（明确指引） 法规要求－－－几类医疗器械。报ＳＤＡ审批。 After the design inputs are developed then a risk assessment follows. In Baxter the risk assessment tool used is the FMEA. Failure Mode and Effects Analysis. The FMEA is a systematic tool for risk assessment. This is done prior to a validation to determine the level of validation required. FMEA’s reduce the cost of defects from a process. We can illustrate the point by using the 1-10-100 rule. The rule says that the price of a defect found during the preventative mode is only the price of that defect. If the defect is found during validation then the prices is ten fold but if it goes through production and into the customer hands then it would be 100 fold. If for example a bag of solution is found to be defective before assembly then the cost is only for that unit, but if we fail to detect it and makes it the next step then the cost is 10 times the original cost in terms of segregation, rework and discard associated. But if we fail to detect the defective unit in plant and is found by a customer then the cost is 100 times the original cost based on customer return, involvement of people and time, loss of credibility and so on. Let us look at the FMEA process. First we outline all of the design requirements and then for each we assign an RPN number. The RPN is based on 3 areas, Occurrence, Severity and Detection. For each area we assign a score from 1 to 5 based o