What authority does 21 CFR 211.22 give the quality unit?

Why

Section 211.22 is the legal root of quality independence in US drug manufacturing. It says the quality control unit can approve or reject materials and finished product, and can review production records to make sure no errors occurred or that any errors were fully investigated. It also approves or rejects every procedure or specification that affects identity, strength, quality and purity, and its own responsibilities must be written down and followed.

In practice the regulation's "quality control unit" covers what most companies split into QA and QC. The rule does not dictate an organization chart. It requires that the unit holding this authority is not overruled by production on a release decision.

The contract clause matters for biotechs that outsource everything. If a CDMO makes the batch, the sponsor's quality unit is still responsible for approving or rejecting it, which is why quality agreements and oversight of the CDMO's records exist. A common interview example is a batch whose test results pass but whose record shows an unexplained yield drop.

The quality unit can and should hold it until the discrepancy is investigated. The limit is that authority without resources is hollow. The regulation also requires adequate laboratories, and the FDA's quality systems guidance expects management to resource the unit.