1 回答
Manufacturers cannot just segregate common products from other product types as a means of dealing with the risk to patient and animal safety. Although this may prevent contamination of other product classes it does not address the possibility for cross contamination within product classes. The approach taken to control cross contamination between individual products within a class produced in the same dedicated area should follow the principles in Q&A 3. This should include implementation of appropriate organisational and technical control measures to prevent contamination between such products within product specific HBELs.
生产商不能只是将一般产品与其它类型产品分隔作为处理患者风险和动物安全的手段。尽管此方法可以防止其它级别产品的污染,但它并未解决同一级别产品中交叉污染的可能性。在同一专用区域内生产同一类别产品,这些产品之间的交叉污染控制所采取的方法应遵守问答3的原则。其中应包括实施恰当的有组织折技术控制措施以控制此类产品之间的污染使其在产品特定的HBEL以内。