What Does GMP Require for Cleaning Records?

Which rules require GMP cleaning documentation?

For finished pharmaceuticals, the requirements sit in 21 CFR Part 211, the current good manufacturing practice regulation. Medical device makers now work under FDA's Quality Management System Regulation in 21 CFR Part 820, which since February 2, 2026 incorporates ISO 13485:2016 by reference. In Europe, EudraLex Volume 4 and its Annex 1 apply.

What belongs in a GMP cleaning log?

A room or equipment log should let an auditor reconstruct the clean without asking anyone. If a field is not needed for a given room, the form should say so rather than leaving a blank that invites questions.

• Room or equipment identifier, matching the SOP and floor plan
• Date, start time and finish time
• Tasks completed, or the SOP number and the steps performed
• Agent name, concentration, lot number and expiry
• Preparation date and in-use expiry of any diluted solution
• Whether the sporicide step was performed
• Signature or initials of the person who cleaned
• Signature of the verifier, where the SOP requires a second check
• Comments, including anything not completed and why

Supporting records auditors ask for next

A clean log rarely stands alone. An auditor who samples a day of entries will often ask for the disinfectant preparation log for the same day, the version of the SOP that was in effect, and the training record showing that each person who signed was trained on that version. Training in the specific operations and in CGMP is required by 21 CFR 211.25, and the training file is how a firm proves it for contractors as well as employees.

Beyond that, expect requests for gowning qualification records, deviation reports and corrective actions linked to cleaning, disinfectant efficacy study reports, change control records for any new agent or frequency, and environmental monitoring trends for the rooms in question. Equipment status labels, showing when an item was cleaned and how long it may stand before reuse, are part of the same paper trail.

Good documentation practice at the point of cleaning

FDA's 2018 guidance on data integrity describes the standard with the acronym ALCOA: records must be attributable, legible, contemporaneously recorded, original or a true copy, and accurate. On a cleaning crew that translates into a handful of habits, and most audit findings come from breaking one of them.

Cleaning validation records are a separate file

Cleaning validation proves that a cleaning process for product-contact equipment removes residues of the previous product, detergent and microorganisms to set limits, usually by swab or rinse sampling. FDA's inspection guide on validation of cleaning processes has shaped expectations here since 1993. Those protocols and reports belong to the manufacturer's validation program. Routine facility cleaning of floors, walls and room surfaces is documented through logs and monitoring instead, and a cleaning contractor's records sit on that side of the line.

How EBS documents cleanroom visits

Every EBS cleanroom program comes with detailed cleaning logs and service reports, so the record of each visit exists when an auditor asks for it. Supervisors inspect through the eHub system, which tracks follow-up and corrective actions to completion. If your quality unit requires its own log forms, those forms are written into the scope at the walkthrough so crews complete them as part of each clean.