21 CFR 211.67 · 21 CFR 211.182
What 21 CFR 211.67 actually
requires you to document
Section 211.67 sits at the center of most FDA preventive maintenance findings. The regulation requires written procedures for cleaning and maintenance of equipment used in drug manufacturing. But the observation that follows an inspection is almost never "you lack a procedure." It is "your records do not demonstrate the procedure was followed."
The gap between having a procedure and being able to prove it was followed is a documentation problem, not a maintenance problem. This page maps the text of § 211.67 to the specific fields a compliant execution record must contain.
What the regulation requires
§ 211.67(b)"Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product."
eCFR full text ↗
§ 211.182"A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication), use and repairs shall be included in individual equipment logs."
eCFR full text ↗
Written procedure referenced
The record must link to the specific SOP that was performed, not a general description of what was done.
Individual attribution
The person who performed the work must be identified. A shift sign-off does not satisfy the requirements under § 211.67(b).
Contemporaneous entry
Steps are documented at the time of execution. A record completed after the fact raises data integrity concerns under ALCOA+.
Equipment identified
The equipment log entry must identify the specific unit, asset ID, equipment number, or unique identifier.
Why most records fall short
The regulation says procedures must be "established and followed." The word "followed" is where inspectors focus. A procedure on file proves the first condition. Only the execution record can prove the second. When that record is incomplete, the finding writes itself.
The three patterns below appear repeatedly in FDA 483 observations tied to § 211.67. Each one is a documentation gap, not a maintenance gap. The maintenance may have been performed correctly. The record just cannot prove it.
Procedure not cited
Record describes work performed but does not reference the SOP number or revision. Investigator cannot verify the approved procedure was used.
Single end-of-task sign-off
Technician signs the work order at completion. No step-level attribution. Investigator cannot determine who performed which steps.
Compressed timestamps
Timestamps on a multi-hour PM are spaced identically or cluster at round numbers. Suggests reconstruction, not real-time recording.
What a compliant record looks like
Every § 211.67 requirement maps to a specific field in the record.
The record below shows a .pruved bundle for a PM task. Each field in the record corresponds directly to a requirement under § 211.67 or § 211.182. Attribution, procedure reference, timestamps, and equipment identity are captured at the moment of execution, not filled in afterward.
§ 211.67(b)
Procedure cited
SOP-PM-0442 · Rev 3
§ 211.67(b)(1)
Individual attribution
EMP-0318 · per step
§ 211.182
Contemporaneous entry
09:14 – 09:28 per step
§ 211.68
Original, uneditable record
Bundle sealed at sign-off
Beyond the individual record
A § 211.67 finding is rarely isolated. When an investigator identifies a documentation gap in one PM record, the corrective action must address the system, not just that record. Your CAPA response needs to demonstrate that every covered piece of equipment will produce compliant records going forward, not just the unit named in the observation.
The .pruved bundle satisfies § 211.67 and § 211.182 by construction. Attribution is captured at the step level. The procedure reference is locked to the bundle when the work order is created. Timestamps are embedded at the moment of execution. None of these elements require a separate documentation step from the technician.
Compliance is a byproduct of how the record is built, not something imposed on it afterward. If you are also working through an active FDA 483 observation, the record format described here is the exhibit your CAPA response needs.
Your next maintenance window creates a record
It should already be compliant.
In 30 minutes we will walk through your equipment list, show you the record each PM produces, and demonstrate exactly how the export satisfies § 211.67 and § 211.182.
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