As described in section 8.3 of Q7A, “in-process controls can be performed by qualified production
department personnel and the process adjusted without prior quality unit(s) approval if the
adjustments are made within pre-established limits approved by the quality unit(s). All tests and
results should be fully documented as part of the batch record”. Section 6.7 further states
“production and laboratory control records of non-critical process steps can be reviewed by
qualified production personnel or other units following procedures approved by the quality
unit(s)”.
