摘要: cGMP中前言Preamble关于双人复核(“double check”或者“independent verification”),1978年 Preamble第6条做了说明,即“The requirement for verification applies to functions that involve human judgment ...
cGMP中前言Preamble关于双人复核(“double check”或者“independent verification”),1978年 Preamble第6条做了说明,即“The requirement for verification applies to functions that involve human judgment and consequently are susceptible to human error” , “Given the possible serious consequences of errors, the "check system" requirement does not seem to be an unjustified burden and, if properly explained, should not be perceived by employees negatively”,应用于涉及人的判断并因此可能发生失误的操作,并且这样的失误可能产生严重的后果;而且FDA根据检查的经验,认为这样的作法可能会让操作人员感觉不太舒服,但不会对员工士气产生不利影响。 随着自动化设备的广泛应用,对自动化设备的运行的复核也成为大家关注的一个问题。FDA在2008年修订 cGMP的一个重要方面,就是加入对自动化设备的复核要求。在 2008年Preamble评论第 19条,FDA阐述了具体要求。自动化设备也要求一定的由人员进行的复核,因为自动化设备也可能出错, “We also noted that the agency is aware that computers are subject to malfunctions, some of which could possibly result in the loss of critical information regarding the manufacturing process or a serious production error and the possible distribution of an adulterated product. Therefore, we stated that while increasingly sophisticated system safeguards and computerized monitoring of essential equipment and programs help protect data, no automated system exists that can completely substitute for human oversight and supervision.”。当然,这种复核并不是说一个人在旁边看着机器操作,而是“合适”程度的复核,由生产厂家自己决定;比如开机前的检查、开机后的试运行、定期的状态检查、IPC取样检查等等,都是一定程度的复核, “We agree that the level, nature, and frequency of such human verification will vary depending on the level of automation used as well as the nature of the system and controls, and the manufacturer has the flexibility and responsibility to determine what is suitable and necessary.”。这个要求对于国外厂家可能是个比较大的问题,因为国外的人工比较贵;对于国内厂家而言,人工不是问题,主要问题是没有要求人员复核的程序,或者检查后也没有记录。 |
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