Standard Operating Procedure for Cleaning Verification Procedure After Dispensing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/013/2025 |
| Supersedes | SOP/ELX/013/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standard and validated procedure for verifying the cleaning status of equipment, utensils, and dispensing areas after the completion of raw material dispensing operations in the Elixir Department, ensuring compliance with GMP and cross-contamination prevention.
2. Scope
This SOP applies to all equipment, dispensing aids, and surfaces used in the dispensing room of the Elixir Department, and covers the verification process post-cleaning before reuse or storage.
3. Responsibilities
- Warehouse Staff:
- Clean the equipment and area as per the cleaning SOP.
- Notify QA for cleaning verification after completion.
- Quality Assurance (QA) Officer:
- Verify cleanliness visually and via swab/sample testing (if required).
- Approve the cleaned equipment and area for next use.
- Warehouse Supervisor:
- Ensure cleaning verification is documented correctly.
See also Elixir Department: SOP for Dispensing Active Pharmaceutical Ingredients for Elixirs - V 2.0
4. Accountability
The Head of Quality Assurance is accountable for ensuring verification of cleaning processes and maintaining associated records.
5. Procedure
5.1 Post-Cleaning Notification
- After completion of cleaning, the warehouse personnel shall inform the QA department for verification.
- Do not use the cleaned equipment or area until QA provides clearance.
5.2 Visual Inspection
- QA officer shall check:
- Equipment surfaces for visible residues or stains
- Interior of scoops, containers, and spatulas
- Floors, weighing stations, balance platforms
- Check for absence of product traces, labels, or powders.
5.3 Swab or Rinse Testing (If Applicable)
- For equipment used with potent, allergenic, or highly active materials:
- QA will perform swab or rinse testing as per cleaning validation protocol.
- Samples are analyzed for chemical or microbiological contamination limits.
- Do not release the equipment until test results meet acceptance criteria.
5.4 Verification Documentation
- QA officer shall complete the Cleaning Verification Log (Annexure-1).
- Affix “Cleaned” status label with:
- Date of cleaning
- Verified by
- Next due for cleaning (if applicable)
5.5 Storage After Verification
- Store cleaned and verified equipment in designated clean storage racks or cabinets.
- Cover open ends of containers or scoops with cling wrap or closures.
5.6 Handling Failures
- If visual inspection fails:
- Send equipment back for re-cleaning.
- Document failure in the Cleaning Verification Log.
- If test results (swab/rinse) exceed limits:
- Quarantine affected equipment.
- Initiate deviation and investigation as per deviation SOP.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- cGMP: Current Good Manufacturing Practices
7. Documents
- Cleaning Verification Log (Annexure-1)
- Swab/Rinse Testing Report (where applicable)
- Status Labels Log
8. References
- 21 CFR Part 211 – Subpart D: Equipment Cleaning and Maintenance
- WHO GMP Guidelines – Pharmaceutical Production
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Verification Log
| Date | Equipment Name | Cleaned By | Verified By | Status | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | Weighing Balance Platform | Rajesh Kumar | Sunita Reddy | Verified | Ready for Use |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Version | New SOP | QA Head |
| 13/04/2025 | 2.0 | Added swab/rinse testing and handling failure | GMP Compliance | QA Head |