All out - of - specification results must be investigated by a defined procedure that complies with global quality standards 所有超标结果必须按照一个明确规定的符合全球质量标准的规程进行调查。
2.
Workshop participants believed that a separate fda guidance is not needed to develop such sops because the existing out - of - specification ( oos ) guidance should suffice 专题小组与会者认为不需要单独的fda指南来开发这样的sop ，因为现在的oos指南有能力做到这一点。
3.
The senior site quality manager ( io ) or quality assurance ( di & a ) is responsible for ensuring that there is a procedure for handling out - of - specification results from laboratory tests that complies with the global quality standards 高级质量管理人员或质量部门应保证具有一个处理实验室试验结果超标的，符合全球质量标准的规程。
