Standard Operating Procedure for Monthly Deep Cleaning Schedule in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/190/2025 |
| Supersedes | SOP/ELX/190/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define a systematic procedure for conducting deep cleaning of all manufacturing equipment, areas, and accessories on a monthly basis to maintain hygiene, prevent contamination, and ensure compliance with cGMP requirements in the Elixir Manufacturing Department.
2. Scope
This SOP is applicable to all processing tanks, transfer lines, agitators, walls, floors, ceilings, HVAC vents, light fittings, and non-product contact surfaces in the Elixir Manufacturing area.
3. Responsibilities
- Production Operator:
- Execute deep cleaning as per schedule and procedure.
- Ensure documentation in cleaning logbook.
- Production Supervisor:
- Verify cleaning completion and cross-check all surfaces.
- QA Officer:
- Perform random inspections and review cleaning records.
- EHS Officer:
- Ensure safety procedures are followed during cleaning.
4. Accountability
The Production Head is accountable for ensuring timely completion of the deep cleaning program. QA is responsible for oversight, verification, and record review.
5. Procedure
5.1 Cleaning Schedule
- Prepare a Monthly Deep Cleaning Calendar at the start of each month.
- Include all equipment and area zones (e.g., mixing room, storage area, corridors).
- Assign cleaning responsibilities to specific personnel with defined dates.
5.2 Pre-Cleaning Preparation
- Shut down all equipment and utilities safely.
- Cover sensitive instruments and electrical panels with polythene sheets.
- Wear PPE: gloves, goggles, mask, boots, apron.
5.3 Deep Cleaning Execution
- Equipment: Dismantle accessories if needed. Clean all outer and non-contact surfaces with 1–2% detergent followed by purified water rinse. Dry with lint-free cloth.
- Floors & Walls: Scrub with approved floor cleaner and mop using detergent followed by two rinses with purified water.
- Ceiling & Vents: Wipe with long-handled mop and detergent solution. Replace filters if visibly dirty.
- Lights & Panels: Clean covers using damp cloth. Avoid spraying directly.
5.4 Post-Cleaning Activities
- Visually inspect all cleaned areas.
- Record cleaning status in the Monthly Deep Cleaning Logbook (Annexure-1).
- QA to sign off after satisfactory verification.
5.5 Special Notes
- Do not perform deep cleaning during product processing hours.
- Report any wall cracks, paint peel-offs, or damaged vents to maintenance.
- Use only validated and approved cleaning agents.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- EHS: Environment, Health & Safety
7. Documents
- Monthly Deep Cleaning Calendar
- Monthly Deep Cleaning Logbook (Annexure-1)
8. References
- 21 CFR Part 211.67 – Cleaning and Maintenance
- WHO TRS 986 – GMP Guidelines
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Monthly Deep Cleaning Logbook
| Date | Area/Equipment | Cleaning Agent | Cleaned By | Verified By (QA) | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | Mixing Room Floor | Neutraclean 1% | Rajesh Kumar | Sunita Reddy | Completed – No deviation |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Updated scope and added HVAC checks | Internal Audit Observation | QA Head |