您是按照药品GMP(2010年修订)要求制定的超标检验数据调查程序吗?
Do you have an OOS investigation procedure, which follows the requirements of the GMP Guidelines (revised in 2010)?
质量体系人员应及时(例如早期)参与制定特殊控制,测试或检验方法,或者确保产品质量所需要的培训程序。
Quality system personnel should participate in the timely (i. e., early) development of special controls, test or inspection methods, or training programs needed to insure product quality.
公司制定《保证公正性程序》,以保证员工工作质量不受来自商业、财务和其他方面的压力和影响,确保检验工作的公正性和独立性。
We formulate "the procedure for the guarantee of justice" to assure the employee work quality not affected by the pressures from commerce, finance and other aspects.
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