21 CFR 211.22(d) - Quality Control Unit Responsibilities and Independence

What it says

The responsibilities and procedures applicable to the quality control unit must be in writing and must be fully followed. The quality unit must have the authority to review and approve or reject all procedures and specifications that could affect the identity, strength, quality or purity of a drug product, and must function independently of production.

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

What it means in practice

• A written quality unit procedure that exists but is not consistently followed is treated the same as having no procedure at all - the citation is for the gap between what the SOP says and what actually happens.
• Independence from production is structural, not just organizational chart language. A quality unit that can be overridden by production or commercial pressure to release a batch does not meet this requirement regardless of its formal reporting line.
• The quality unit's authority must extend to specifications and procedures, not only to final batch disposition decisions made at the end of the process.

What FDA inspectors look for

• Whether quality unit review actually occurred and was documented for the specific batches, procedures or changes examined during the inspection, not just whether a quality unit exists on paper.
• Evidence of production or commercial pressure influencing a quality decision, including batches released despite open investigations or incomplete documentation.
• Whether quality unit personnel demonstrate, through interview, genuine understanding of the basis for their approval decisions rather than simply confirming a checklist was completed.

Related regulations