Regulayer / The 143 laws / Pharma & life sciences
FDA · 21 CFR 211.22
The quality unit’s authority to approve or reject.
Instrument: Regulation, legally bindingApplies to: Finished pharmaceutical manufacturing (US).
What the signed record shows
That a named, authorised person in the quality unit made the approval or rejection decision, and when.
The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.
Citation: 21 CFR 211.22, with 211.68 on automated systems
What to do about it
Keep the evidence this asks for, as the work happens.
A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer. It runs inside your own environment and nothing has to leave it.
Life sciences: how the control worksOr verify a real record, free →
Part of the Regulayer proof catalogue: 143 laws and standards, one sealed engine. This page is a product description, not legal advice.
What the regulation requires, section by section
21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. The sections that vest authority in a named human function:
- §211.22(a)
- A quality control unit shall have the responsibility and authority to approve or reject all components, containers, in-process materials, packaging, labelling and drug products.
- §211.22(c)
- The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality and purity of the drug product.
- §211.22(d)
- The responsibilities and procedures applicable to the quality control unit shall be in writing and followed.
- §211.68
- Where automatic, mechanical or electronic equipment is used, input to and output from it shall be checked for accuracy, and changes to such systems shall be made only by authorised personnel.
This is the provision FDA reached for in April 2026 when AI-generated specifications, procedures and master production records entered a quality system without review. No new AI duty was created: sixty-year-old quality-unit law was applied to AI output. The reading that matters is that the quality unit’s accountability is not transferable.
Built against the primary text at the eCFR. Verified 17 August 2026.
