SOP for Cleaning of a Quality Control Laboratory

In short: This is an example SOP for routine cleaning of a pharmaceutical QC laboratory. It covers floors, walls, doors, windows, benches, reagent racks and instruments, and the cleaning record. GMP expects premises to be cleaned under detailed written procedures; the frequencies and agents below are example in-house criteria that you must adapt to your own site and quality system.

Objective

To lay down a procedure for routine cleaning of the Quality Control (QC) laboratory so that dust and contamination do not affect test results or the safety of staff.

Scope

This example SOP applies to the QC laboratory at a pharmaceutical manufacturing site. Microbiology, sterility-testing and other special areas normally need their own cleaning and disinfection procedures.

Why laboratory cleaning is written down

• EU GMP Part I, Chapter 3 (Premises and Equipment), paragraph 3.2, says premises should be cleaned and, where applicable, disinfected according to detailed written procedures. Paragraphs 3.26 to 3.29 set out expectations for QC areas, such as laboratories designed to suit their operations and with enough space to avoid mix-ups and cross-contamination.
• 21 CFR 211.56(b) and (c) require written sanitation procedures that assign responsibility and describe how often cleaning is done, the methods, and the equipment and materials used, and that these procedures are followed.
• WHO good practices for pharmaceutical QC laboratories say that measures should be in place to ensure good housekeeping, and list cleaning of laboratory facilities, including bench tops, equipment and work stations, among the topics the laboratory should have procedures for. In the current edition (TRS 1052, Annex 4, 2024) these are paragraphs 5.18 (good housekeeping and cleaning routines) and 3.7 (procedures, including cleaning of laboratory facilities); in the earlier 2010 edition (TRS 957, Annex 1) they were sections 7.2 and 2.3.

Responsibility

• The QC officer or executive performing the work follows this SOP and fills in the cleaning record.
• The Head of QC, or a designee, is responsible for implementing the SOP and for periodic checks that it is followed.
• Cleaning staff, if used, are trained on this SOP by QC before working in the laboratory.

Procedure

Floor

1. Remove dust with a vacuum cleaner and empty the collected dust into the dustbin.
2. Dispose of the waste from the dustbin at the designated garbage area.
3. Prepare the disinfectant fresh, as per the disinfectant preparation annexure, and mop the floor.
4. Rotate between two or three disinfectants on alternate weeks (example in-house criterion), and let the floor air dry.

Benches, reagent racks and instruments

1. Before cleaning any instrument, confirm that it is not in use and switch it off.
2. Wipe instruments and reagent racks with a clean, dry duster. Do not spray liquids on instruments.
3. Clean the testing bench with a damp cloth, then a dry cloth.
4. Clean instruments and benches before starting work each day.

Walls, doors, windows and ceiling

1. Wipe doors and windows with a clean duster.
2. Clean walls and the wall-ceiling corners with a vacuum cleaner fitted with a soft nylon brush.
3. Remove spots or stains on walls with diluted cleaning solution.
4. Remove spots on glass of windows and doors with a glass-cleaning solution.
5. Where disinfectant is used for these surfaces, rotate between two or three disinfectants on alternate weeks, as for the floor.

Frequency (example in-house criteria)

Records

Record each cleaning activity (floor, walls, doors, windows, reagent racks, ceiling, benches) in the Cleaning Record of Quality Control Laboratory, and record disinfectant preparation in the disinfectant preparation record. Keep these records with other GMP records for at least 1 year after the expiry date of the respective product batch (EU GMP Part I, Chapter 4, paragraph 4.11; 21 CFR 211.180(a)), or longer if local law or the marketing authorisation requires.

Annexures

• Annexure I: Cleaning Record of Quality Control Laboratory.
• Annexure II: Preparation of Disinfectant (agent, concentration and contact time are set by your site’s validated or qualified disinfection programme).

See also

• General safety rules of a quality control laboratory
• SOP for safety in a quality control laboratory
• SOP on cleaning of glassware used in chemical and instrument analysis
• Records maintenance in a quality control laboratory

Abbreviations

• QC: Quality Control
• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice

Frequently asked questions

Does GMP fix how often a QC laboratory must be cleaned?

No. The guidelines cited here require written procedures that define frequency, methods and materials, but they do not prescribe one frequency for every laboratory. You set it from your own risk assessment and review it when needed.

Why rotate disinfectants?

Many sites rotate agents to reduce the chance of resistant organisms building up. This is a site practice, mainly relevant to microbiological control, and it is not a general requirement for every chemical QC laboratory.

Who should clean instruments?

Normally the analyst or a trained person, because instruments must be switched off and cleaned without damaging them. General housekeeping staff should not clean instruments unless trained for it.

References

1. European Commission, EudraLex Volume 4, EU GMP Guidelines, Part I, Chapter 3: Premises and Equipment (paragraphs 3.2 and 3.26 to 3.29; in operation since 1 March 2015).
2. European Commission, EudraLex Volume 4, Part I, Chapter 4: Documentation, paragraph 4.11.
3. US FDA, 21 CFR 211.56 Sanitation and 21 CFR 211.180(a), General requirements for records (eCFR, current).
4. WHO, WHO good practices for pharmaceutical quality control laboratories, WHO Technical Report Series No. 1052, 2024, Annex 4 (current edition; paragraphs 3.7 and 5.18).
5. WHO, Good practices for pharmaceutical quality control laboratories, WHO Technical Report Series No. 957, 2010, Annex 1 (earlier edition; sections 2.3 and 7.2).