Is it acceptable to blend multiple lots that do not have a physical property specification to meet a blended lot physical property specification, example bulk volume particle size? If the material is out of specification for physical properties, can it be blended with other lots to meet these specifications? In all cases, appropriate validation would be conducted.

As an example, a manufacturer may have an API that they’re selling to multiple customers, and a
particular customer for some reason has provided you a particle size specification. So, this is now
a customer-defined specification that you get when the order comes in and is within the range of
particle size distribution of the process. Thus, to meet the new, tighter criteria, selected batches
chosen and blended. This results in a batch that meets the desired specification of the customer.
This appears to be within the expectations of Section 8.4 of Q7A, provided the individual batches
selected are within the manufacturers initial specifications. While the justification for doing such a
blending would need to be carefully developed, it does not appear to represent dilution of a
known quality problem for the materials that would not be permitted under Q7A.