appropriate specifications 如何理解呢？

beiwei5du

8.41 Out-of-specification batches should not be blended with other batches for the purpose of meeting specifications. Each batch incorporated into the blend should have been manufactured using an established process and should have been individually tested and found to meet appropriate specifications prior to blending.

问题：What  is  meant  by  ‘appropriate specifications (of each batch) prior to blending’ [ICH Q7, Section 8.41]?  

答案：As a principle, no batches with Out of Specification (OOS) results should be blended [ICH Q7,  Section
8.41].   Blending is defined in [ICH Q7,  Section  8. 40].   Individual intermediate and/or API batches
should  demonstrate  conformance  with  the  filed  specifications  prior  to  blending .    In  regions  or
circumstances where there are intermediates and/or APIs that do not require filing, conformance with
the release specification should be demonstrated .  

如何理解呢？？？