1What 21 CFR 211.182 requires.
Section 211.182 requires “a written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use” in individual equipment logs “that show the date, time, product, and lot number of each batch processed”. The people who perform and double-check the cleaning and maintenance date and sign or initial the log; where automated equipment does the work, the person verifying it signs. “Entries in the log shall be in chronological order.”¹
Equipment dedicated to one product does not need an individual log, provided its lots follow in numerical order and are manufactured in numerical sequence. In that case the records of cleaning, maintenance and use are part of the batch record.¹
The log sits alongside other Part 211 equipment rules. Written procedures for cleaning and maintenance assign responsibility, set schedules, describe methods in enough detail to disassemble and reassemble equipment, and require removal of the previous batch identification, protection of clean equipment and inspection for cleanliness immediately before use; records of maintenance, cleaning, sanitising and inspection are kept as 211.180 and 211.182 specify. Major equipment carries a distinctive identification number recorded in the batch record, and automatic, mechanical and electronic equipment is calibrated, inspected or checked under a written programme with written records.¹
| Entry | What it records | Rule |
|---|---|---|
| Use | Date, time, product and lot number of each batch processed | 21 CFR 211.182 |
| Cleaning | The cleaning done, dated and signed or initialled by the person who did it and the person who checked it | 21 CFR 211.182, 211.67 |
| Maintenance | Non-routine maintenance, signed in the same way | 21 CFR 211.182 |
| Inspection before use | Inspection for cleanliness immediately before use | 21 CFR 211.67(b)(6) and (c) |
| Calibration and checks | Calibration checks and inspections of automatic, mechanical and electronic equipment | 21 CFR 211.68(a) |
| Identification | The equipment’s distinctive number, recorded in the batch record | 21 CFR 211.105(b) |
2What EU GMP asks for.
EU GMP Chapter 4, section 4.31, says logbooks “should be kept for major or critical analytical testing, production equipment, and areas where product has been processed”. They record “in chronological order, as appropriate, any use of the area, equipment/method, calibrations, maintenance, cleaning or repair operations, including the dates and identity of people who carried these operations out”.² Its scope reaches analytical equipment and processing areas as well as production equipment, and it adds calibrations and repairs to use, cleaning and maintenance.
Chapter 3 sets the conditions the log evidences. Equipment is cleaned to detailed written procedures and stored clean and dry; measuring, weighing, recording and control equipment is calibrated and checked at defined intervals, with adequate records; and defective equipment is removed from production and quality control areas or “clearly labelled as defective”.³
For active substances, ICH Q7 section 6.20 asks for the same content as 211.182: the date, time if appropriate, product and batch number of each batch processed, and the person who did the cleaning and maintenance.⁴
3How entries are made and corrected.
EU GMP asks for records to be made “at the time each action is taken”, handwritten entries to be legible and indelible, and any alteration to be signed and dated so that the original information can still be read, with the reason where appropriate.² ICH Q7 asks the same of corrections.⁴
For paper logbooks, FDA’s data integrity guidance of December 2018 gives bound, paginated notebooks stamped by a document control group as an example of good control, because unofficial notebooks and missing pages are easy to detect. Numbered sets of blank forms can be issued and reconciled when complete.⁵
4Status labels and the log.
FDA’s CGMP questions and answers address whether equipment status labels, such as “clean, ready for use” or the lot being mixed, must be kept with the batch record. The regulations require cleaning and use logs for non-dedicated equipment to be retained, but not temporary status labels, and FDA sees no value in keeping them as well as the log. Any label “should be correct, legible, readily visible, and associated with the correct piece of equipment”, and its information should match the log; a dry-erase board is also acceptable, and an investigator may check that the two agree.⁶
5Electronic logbooks and maintenance systems.
An electronic logbook or maintenance system that holds the records 211.182 requires is a computer system used for CGMP work. Part 211 requires controls so that only authorised people change records, checks on input and output, and a backup of the data.¹ Under FDA’s 2003 guidance, Part 11 applies when records a predicate rule requires are kept electronically in place of paper.⁷ FDA’s data integrity guidance says each CGMP workflow on a computer system is an intended use “to be checked through validation”, with the extent commensurate with the risk, and that where one system serves CGMP and non-CGMP functions, the potential for the non-CGMP functions to affect CGMP operations should be assessed.⁵
In the EU, Annex 11 “applies to all forms of computerised systems used as part of a GMP regulated activities”. The application should be validated and the IT infrastructure qualified, the extent of validation should follow “a justified and documented risk assessment”, and replacing a manual operation should cause no decrease in product quality, process control or quality assurance.⁸
6How it runs in Seal.
Seal’s electronic logbooks record equipment, room and shift events against the procedure version, with event time and entry time kept separate. Cleaning, inspection and planned use stay separate facts, so a cleaned vessel is not read as ready; corrections keep the original entry; unfinished checks carry into the shift handover with an owner and a next action; and events link to the batches, maintenance and deviations they concern.
In the maintenance blueprint, the plan, work order, parts, readings and return-to-service review share records with the equipment, laboratory and quality work they affect, and release remains a separate, authorised decision. The equipment blueprint connects calibration, qualification, cleaning and maintenance evidence to the workflow that selects the asset, so a missing prerequisite stops the configured path, and recorded uses lead to the samples and batches to assess when a check fails.
References
- 121 CFR Part 211, Current good manufacturing practice for finished pharmaceuticals, including 211.67, 211.68, 211.105 and 211.182, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211 (read 6 November 2026) - 2EudraLex Volume 4, Chapter 4: Documentation, European Commission, in operation 30 June 2011. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ chapter4_ 01- 2011_ en_ 0. pdf (read 6 November 2026) - 3EudraLex Volume 4, Part I, Chapter 3: Premises and Equipment, European Commission, 13 August 2014, in operation 1 March 2015. https:/
/ health. ec. europa. eu/ document/ download/ 18d76565- 137b- 41d2- a602- 794527f708c1_ en?filename=chapter_ 3. pdf (read 6 November 2026) - 4ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH, 10 November 2000. https:/
/ database. ich. org/ sites/ default/ files/ Q7%20Guideline. pdf (read 6 November 2026) - 5Data Integrity and Compliance With Drug CGMP: Questions and Answers, guidance for industry, FDA, December 2018. https:/
/ www. fda. gov/ media/ 119267/ download (read 6 November 2026) - 6Questions and Answers on Current Good Manufacturing Practice Requirements: Production and Process Controls, question 1, FDA, page content current as of 5 May 2026. https:/
/ www. fda. gov/ drugs/ guidances- drugs/ questions- and- answers- current- good- manufacturing- practice- regulations- production- and- process (read 6 November 2026) - 7Guidance for Industry: Part 11, Electronic Records; Electronic Signatures, Scope and Application, FDA, August 2003. https:/
/ www. fda. gov/ regulatory- information/ search- fda- guidance- documents/ part- 11- electronic- records- electronic- signatures- scope- and- application (read 6 November 2026) - 8EudraLex Volume 4, Annex 11: Computerised Systems, European Commission, in operation 30 June 2011. https:/
/ health. ec. europa. eu/ system/ files/ 2016- 11/ annex11_ 01- 2011_ en_ 0. pdf (read 6 November 2026)
AQuestions and answers
Does dedicated equipment need its own logbook?
Not under 21 CFR 211.182, provided the lots made on it follow in numerical order and are manufactured in numerical sequence. The cleaning, maintenance and use records then go in the batch record instead. EU GMP still expects a logbook for major or critical production equipment.
Do we have to keep equipment status labels?
No. FDA has said the regulations require cleaning and use logs for non-dedicated equipment to be retained, but not temporary status labels. A label or board should be correct, legible, readily visible, on the right equipment and consistent with the log while it is in use.
Does routine maintenance have to go in the log?
Part 211 excludes routine maintenance such as lubrication and adjustments from the equipment log, while cleaning and other maintenance must be logged. The maintenance itself still follows written procedures and schedules, and EU GMP asks logbooks to record maintenance and repair operations as appropriate.
Does a CMMS or electronic logbook need to be validated?
If it holds GMP records, such as the equipment logs Part 211 requires, yes. FDA expects each CGMP workflow on a computer system to be validated for its intended use, and EU Annex 11 applies to every computerised system used in GMP work. The extent of validation follows a documented risk assessment, and where one system also serves non-GMP work, the risk of those functions affecting GMP operations is assessed.
How should a logbook entry be corrected?
Make the correction so the original entry can still be read, then sign and date it, with the reason where appropriate. Entries should be made at the time of the activity, and Part 211 requires them to be in chronological order.
Which equipment needs a logbook?
In the US, major equipment used in manufacturing, unless it is dedicated to one product with lots made in sequence. In the EU, major or critical production and analytical equipment, and the areas where product has been processed.