21 CFR 211.22(a) - Quality Control Unit - General Authority

What it says

There must be a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products, and the authority to review production records to assure no errors have occurred.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This subsection establishes that a quality control unit must exist at all, with defined authority spanning materials, in-process control and finished product, while 211.22(d) specifically addresses whether that unit's own written procedures are followed, together forming the complete quality unit requirement.
• The authority described here is comprehensive, covering the full material and product lifecycle from incoming components through finished drug product, not limited to final release decisions alone.
• Review of production records specifically for error detection is named as an explicit quality unit function, distinct from and in addition to the investigation obligations under 211.192.

What FDA inspectors look for

• Whether the quality unit's actual authority, as exercised in practice, genuinely spans the full scope this provision describes, materials, in-process, packaging and finished product, rather than being narrowly limited to final release alone.
• Whether production record review by the quality unit is genuinely substantive, capable of catching errors, rather than a cursory sign-off.
• Whether the quality unit's authority is structurally protected from being overridden by production or commercial pressure in practice, not just on an organisational chart.

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