Standard Operating Procedure for Weekly Preventive Cleaning in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/181/2025 |
| Supersedes | SOP/ELX/181/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standard procedure for performing weekly preventive cleaning of manufacturing equipment, accessories, and working areas in the Elixir Department to prevent accumulation of residues and ensure a state of readiness.
2. Scope
This SOP applies to all product-contact and non-contact equipment surfaces, external areas of processing tanks, floors, walls, utilities, and fixtures in the Elixir manufacturing area that require preventive cleaning at weekly intervals.
3. Responsibilities
- Production Operator:
- Perform cleaning activities as per schedule.
- Ensure proper documentation of cleaning activity.
- Production Supervisor:
- Verify the completion of preventive cleaning and sign off the checklist.
- QA Officer:
- Perform random verification and review cleaning records weekly.
4. Accountability
The Production Head is accountable for ensuring compliance with the preventive cleaning schedule. QA is responsible for reviewing records and ensuring the cleaning effectiveness.
5. Procedure
5.1
Schedule and Planning
- Prepare a weekly cleaning calendar for each processing area, listing equipment, location, and responsible personnel.
- Display the calendar in the production area and update with completion status every week.
5.2 Materials Required
- Approved cleaning detergent (1–2% solution)
- Lint-free cloths and scrubbers
- Sanitizer (e.g., 70% IPA)
- Approved brushes and mops
- Buckets labeled for detergent and rinse water
5.3 Cleaning Steps
- Switch off equipment and disconnect from utilities before cleaning.
- Perform the following cleaning tasks:
- Wipe down external surfaces of tanks, vessels, and pipelines.
- Clean handles, clamps, and equipment support stands.
- Sweep and mop floors with detergent followed by water rinse.
- Wipe wall panels, light fixtures, and glass view panels.
- Sanitize contact surfaces using 70% IPA after drying.
- Inspect cleaned areas and note any issues (e.g., corrosion, residue).
- Escalate observations requiring maintenance or deep cleaning.
5.4 Frequency and Exceptions
- Perform preventive cleaning once every 7 days.
- If production schedule does not allow cleaning on the 7th day, extend up to 9th day with QA approval and justification.
- Document reasons for delay in the cleaning calendar and get countersigned by Production Head and QA.
5.5 Documentation
- Record each weekly cleaning activity in the Preventive Cleaning Logbook (Annexure-1).
- Supervisor to verify and sign upon completion.
- QA to review weekly and maintain cleaning compliance summary.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- IPA: Isopropyl Alcohol
7. Documents
- Preventive Cleaning Logbook (Annexure-1)
- Weekly Cleaning Calendar
8. References
- 21 CFR Part 211.67 – Cleaning and Maintenance
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO TRS 986 Annex 4 – Pharmaceutical Cleaning Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Preventive Cleaning Logbook
| Date | Equipment/Area | Cleaning Agent | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | Tank Exterior – MXR-ELX-07 | 1% Neutraclean | Rajesh Kumar | Sunita Reddy | Completed – No Observations |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added weekly calendar and delay protocol | Audit Recommendation | QA Head |