Would you provide a definition of adulteration in terms of Q7A, for example, if a rubber band falls into a tank at the beginning of a process and can be removed and shown to have lost no extractables and not impacted product quality, is it adulteration? Can removal be considered a deviation or reprocessing?

First of all, adulteration is when it’s not manufactured in accordance with Good Manufacturing
Practices. The elastic band we’re talking about is more related to contamination.
Section 5.1 says, “any substance associated with the operation of equipment, such as lubricants,
heating fluids, coolants, should not contact Intermediates or APIs, so as to alter the quality of the
APIs or Intermediates beyond the official or other established specifications. Any deviation from
this practice should be evaluated to ensure there are no detrimental effects on the material’s
fitness for use”. Wouldn’t you think, by extension, when you’re talking about something that
comes in contact with the process, even if it’s not part of the equipment – it’s an elastic, a polybag
in which the material was stored that comes in contact – you would evaluate it the same way, that
it’s not detrimental and it does not alter the material beyond its specifications and its suitability for
use?
In that particular example, if you are using a lubricant and you get some of that lubricant in your
API, under this section, as long as it does not alter the quality of the API beyond its established
standard, then what you have is some contamination, but it would not be considered adulteration
at that point.