GMP验证过程介绍讲述.ppt

* There are 3 distinct qualification phases to any protocol. The… * We have talked about validations, qualifications and protocols. To prevent any confusion let me clarify the differences… * Let us look at the first qualification phase, the IQ. An Installation Qualification covers all of the aspects of an installation, let us examine in the next slide some examples.. * This is not an all inclusive (包含一切) list and other items may apply. * The 2nd phase of the qualification is the Operational Qualification. This is the phase in which we establish the process that will finally meet the desired requirements. Usually, this is where most of the work will be occurring. * In addition, this is also where we do the… * Let us look into more detail at the development of Operating Parameters within the OQ Qualification. There are 3 areas that need to be address, the first is establish what are the key process parameters and one can use screening experiments to define them. Secondly the parameters need to be optimized and Response Surface Study are the tools used for this. Finally process stability needs to be established. * 例如袋子的热封边，根据设计输入我们已经知道在热封强度，热封完整性方面的要求，那么对于热封这样一个过程，什么会影响到热封强度和热封完整性呢，这时候我们就需要坐下来通过验证团队的从人、机、物、法、环几方面思考讨论确定有哪些影响因素，然后通过试运行和热封效果的测试，看哪个因素的变化会引起热封强度的较大变化，那么那个因素就是关键参数。 * The second step is to optimize the parameters. If we assume this is a high risk process then we use the worst case condition to confirm the parameters * This is where we will evaluate the results of a process in terms of the desires requirements. A CpK of 1.33 forces your process to be centered and smaller deviation.　意味着１０－１００ＤＰＭ的质量水平。 In other words, this is where we look at the variations of a process. For example, if an important requirement is that a cap for a bottle be removed with a force of 15 in-oz +/- 3 in-oz, then we would use these specification limits to compare them to actual cap removal force from a bottle capping process. Depending on the average and standard deviation