including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in...
Specify which tests are performed by your facility and which if any are performed by a contract testing laboratory. •一份化学和微生物规格清单,包括测试方法,用于在批次处置决定之前分析每个批次的药品。说明哪些测试是由企业的设备执行的,如果有的话,哪些是由合同测试实验室执行的。 o An action plan ...