Standard Operating Procedure for Cleaning and Disinfection of Dosing Rooms in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/118/2025 |
| Supersedes | SOP/BA-BE/118/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the standardized cleaning and disinfection procedures for dosing rooms used in BA/BE studies to maintain aseptic conditions, minimize cross-contamination, and comply with applicable GCP and hygiene standards.
2. Scope
This SOP applies to all dosing rooms within the clinical unit where investigational products are administered to study volunteers. It includes procedures for pre-dose, post-dose, and scheduled deep cleaning activities.
3. Responsibilities
- Housekeeping Personnel: Perform cleaning and disinfection as per defined schedule using approved cleaning agents.
- Clinical Research Coordinator: Verifies cleanliness before volunteer entry and after dosing procedures.
- QA Officer: Conducts periodic audits and reviews cleaning records.
- Facility Supervisor: Ensures availability of cleaning supplies and trained staff.
4. Accountability
The Head of Clinical Facility Operations is accountable for ensuring that dosing rooms remain compliant with hygiene protocols and ready for study use at all times.
5. Procedure
5.1 Types of Cleaning
- Routine Cleaning: Conducted before and after each dosing session.
- Deep Cleaning: Conducted weekly or after any spill, contamination, or unplanned event.
5.2 Cleaning Agents and Materials
- Use only approved disinfectants (e.g., 70% IPA, hypochlorite solution 0.5%, or quaternary ammonium compounds).
- Ensure availability of:
- Disposable gloves
- Face masks
- Clean mop and lint-free wipes
- Yellow/red waste bins for disposal
5.3 Routine Cleaning Procedure
- Wear PPE before entering the dosing room.
- Wipe all surfaces (beds, tables, dosing counters, IV stands) with 70% IPA.
- Disinfect floors starting from farthest corner to exit using freshly prepared disinfectant solution.
- Empty waste bins and dispose of used PPE and materials in designated biomedical waste containers.
- Document in Annexure-1: Dosing Room Cleaning Log.
5.4 Deep Cleaning Procedure
- Remove all equipment and wipe down walls, fixtures, air vents, and high-contact surfaces.
- Use fumigation or fogging if directed by QA during spill or contamination events.
- Replace bed linens, curtains, and disposable drapes.
- Document activity in Annexure-2: Dosing Room Deep Cleaning Record.
5.5 Cleaning Validation and Spot Checks
- QA shall conduct random swab testing (optional based on policy) for surface hygiene.
- Audit housekeeping logs weekly using Annexure-3: QA Cleaning Audit Sheet.
5.6 Post-Cleaning Readiness Check
- Clinical Research Coordinator to inspect and confirm readiness using Annexure-4: Pre-Dosing Room Clearance Checklist.
- No volunteer entry shall be allowed without documented clearance.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- IPA: Isopropyl Alcohol
- SOP: Standard Operating Procedure
7. Documents
- Dosing Room Cleaning Log – Annexure-1
- Dosing Room Deep Cleaning Record – Annexure-2
- QA Cleaning Audit Sheet – Annexure-3
- Pre-Dosing Room Clearance Checklist – Annexure-4
8. References
- ICH E6(R2) – Good Clinical Practice
- WHO Guidelines for Good Hygiene Practices
- Biomedical Waste Management Rules – India
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Dosing Room Cleaning Log
| Date | Time | Area Cleaned | Performed By | Verified By |
|---|---|---|---|---|
| 17/04/2025 | 07:30 AM | Room A | Sunita Reddy | Rajesh Kumar |
Annexure-2: Dosing Room Deep Cleaning Record
| Date | Type | Agent Used | Performed By | Remarks |
|---|---|---|---|---|
| 15/04/2025 | Fogging | Hydrogen Peroxide | Ajay Verma | Completed |
Annexure-3: QA Cleaning Audit Sheet
| Date | QA Auditor | Area Audited | Observations | Corrective Actions |
|---|---|---|---|---|
| 16/04/2025 | Meena Joshi | Room B | Surface streaks | Re-cleaned |
Annexure-4: Pre-Dosing Room Clearance Checklist
| Room | Inspected By | Date | Checkpoints Cleared | Ready for Use |
|---|---|---|---|---|
| Dose Room C | Rajesh Kumar | 17/04/2025 | Yes | Yes |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | Regulatory Requirement | QA Head |
| 17/04/2025 | 2.0 | Enhanced procedures, added readiness checklist | Annual Review | QA Head |