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随着GMP实施工作的日益深化,人们对验证的重要性已逐步认识。然而在开展这项工作时又共同面临着两个基本问题。一是如何验证。因为这是一项涉及厂房、设施、工艺、管理等方面的综合性工作,如果制药企业都要自行探索,势必事倍功半,并且还会造成大量重复劳动:二是如何检查。要是对验证缺乏科学的论证和检查,单凭主观意愿和口头指令,会误导验证,使验证结果失去可信性。 虽然大量验证活动需要在制药企业完成,但因为它
With the deepening of the implementation of GMP, people have gradually realized the importance of verification. However, in carrying out this work, they jointly face two basic problems. First, how to verify. Because this is a comprehensive work involving plant, facilities, technology, management and other aspects, if the pharmaceutical companies have to explore on their own, it will inevitably be more effective and will result in a lot of duplication of work: the second is how to check. If the verification of the lack of scientific argument and examination, alone subjective will and verbal instructions, will mislead the verification, the verification results lose credibility. Although a large number of validation activities need to be done in the pharmaceutical business, but because of it