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

1. Routine Cleaning: Conducted before and after each dosing session.
2. Deep Cleaning: Conducted weekly or after any spill, contamination, or unplanned event.

5.2 Cleaning Agents and Materials

1. Use only approved disinfectants (e.g., 70% IPA, hypochlorite solution 0.5%, or quaternary ammonium compounds).
2. Ensure availability of:
   • Disposable gloves
   • Face masks
   • Clean mop and lint-free wipes
   • Yellow/red waste bins for disposal

5.3 Routine Cleaning Procedure

1. Wear PPE before entering the dosing room.
2. Wipe all surfaces (beds, tables, dosing counters, IV stands) with 70% IPA.
3. Disinfect floors starting from farthest corner to exit using freshly prepared disinfectant solution.
4. Empty waste bins and dispose of used PPE and materials in designated biomedical waste containers.
5. Document in Annexure-1: Dosing Room Cleaning Log.

5.4 Deep Cleaning Procedure

1. Remove all equipment and wipe down walls, fixtures, air vents, and high-contact surfaces.
2. Use fumigation or fogging if directed by QA during spill or contamination events.
3. Replace bed linens, curtains, and disposable drapes.
4. Document activity in Annexure-2: Dosing Room Deep Cleaning Record.

5.5 Cleaning Validation and Spot Checks

1. QA shall conduct random swab testing (optional based on policy) for surface hygiene.
2. Audit housekeeping logs weekly using Annexure-3: QA Cleaning Audit Sheet.

5.6 Post-Cleaning Readiness Check

1. Clinical Research Coordinator to inspect and confirm readiness using Annexure-4: Pre-Dosing Room Clearance Checklist.
2. 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

1. Dosing Room Cleaning Log – Annexure-1
2. Dosing Room Deep Cleaning Record – Annexure-2
3. QA Cleaning Audit Sheet – Annexure-3
4. 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