Some drums of an API were in a room next to a smoky fire. There’s no visible damage to the inner packaging, although the outer drums were sooty. 211 specifies that the drug product would need to be destroyed. What would the recommendation be with respect to the intent of Q7A in destruction or reprocessing? The material still meets the established specifications.

Q7A Section 4.5 – Returns – may address the issue, although this may not be returned material. It
says, “If the conditions under which returned Intermediates or APIs have been stored or shipped,
before or during the return, or the condition of their containers casts doubt on their quality, the
returned Intermediates or APIs should be reprocessed, reworked, destroyed, as appropriate”.
You have a little more flexibility with APIs because, if there’s any concern regarding its quality,
you could reprocess it, rework it, or destroy it.