Section 12.1 of Q7A clearly states, Validation should extend to those operations determined to
be critical to the quality and purity of the API. It is left to the API manufacturer to determine which
steps are considered critical in their process.
Q7A does not expect you to validate non-critical steps, nor are you expected to validate each
subsequent step in the process once you initiate validation. This later point is reiterated in section
1.3 of Q7A, where it states, “it should be noted that the fact that a company chooses to validate a
process step does not necessarily define that step as critical”.
