SOP Guide for Pharma

BA-BE Studies: SOP for Clinical Trial Facility Cleaning and Hygiene – V 2.0

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BA-BE Studies: SOP for Clinical Trial Facility Cleaning and Hygiene – V 2.0

Standard Operating Procedure for Clinical Trial Facility Cleaning and Hygiene in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/078/2025
Supersedes SOP/BA-BE/078/2022
Page No. Page 1 of 10
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To establish standardized cleaning and hygiene practices for clinical trial facilities conducting Bioavailability/Bioequivalence (BA/BE) studies to ensure subject safety, regulatory compliance, and data integrity.

2. Scope

This SOP applies to all clinical areas including volunteer rooms, sample collection areas, dosing rooms, washrooms, and equipment zones within the BA/BE facility.

3. Responsibilities

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4. Accountability

The Facility Manager is accountable for ensuring all cleaning procedures are executed as per schedule and hygiene SOPs are followed rigorously throughout the clinical trial period.

5. Procedure

5.1 Cleaning Schedules

  1. Classify cleaning frequency:
    • Daily: Volunteer rooms, corridors, toilets, dosing room, sample collection bay
    • Weekly: Storage areas, air vents, ceiling corners
    • Monthly: Deep cleaning and disinfection of walls, high-touch surfaces
  2. Use Annexure-1: Cleaning Schedule Log for documentation.

5.2 Approved Cleaning Materials

  1. Use hospital-grade disinfectants (e.g., 1% sodium hypochlorite, 70% IPA) validated for surfaces.
  2. Store cleaning agents in labeled containers with MSDS available.
  3. Prepare fresh solution daily; discard unused disinfectants as per disposal SOP.

5.3 Cleaning Methodology

  1. Wear gloves, masks, and disposable aprons while cleaning clinical areas.
  2. Follow unidirectional wiping from clean to dirty areas.
  3. Change mops and cloths between rooms to prevent cross-contamination.
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5.4 Waste Management

  1. Segregate biohazardous and general waste as per biomedical waste rules.
  2. Dispose of used PPE and cleaning material in red/yellow bags as appropriate.

5.5 Pest Control

  1. Schedule pest control every quarter using vendor services.
  2. Document activities in Annexure-2: Pest Control Log with invoices and MSDS.

5.6 Monitoring and Audit

  1. CRC must inspect and sign off each cleaning task daily.
  2. QA to verify random areas weekly and file audit observations if any.

5.7 Handling Spills and Emergencies

  1. Use spill kits for blood or chemical spills; inform CRC and document immediately in Annexure-3: Spill Incident Report.

6. Abbreviations

7. Documents

  1. Cleaning Schedule Log – Annexure-1
  2. Pest Control Log – Annexure-2
  3. Spill Incident Report – Annexure-3

8. References

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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 Schedule Log

Date Area Cleaned Type Done By Checked By Remarks
17/04/2025 Dosing Room Daily Vijay Sharma Sunita Reddy Clean

Annexure-2: Pest Control Log

Date Vendor Name Areas Covered Invoice No. Reviewed By
01/04/2025 PestSafe India All Clinical Zones INV-1024 Dr. Arvind Shah

Annexure-3: Spill Incident Report

Date Area Type of Spill Cleaned By Remarks
15/04/2025 Sample Collection Bay Blood Nisha Verma Disinfected with 1% NaOCl

Revision History:

Revision Date Revision No. Details Reason Approved By
10/01/2022 1.0 Initial Release Operational SOP QA Head
17/04/2025 2.0 Expanded annexures and emergency response section Audit requirement QA Head
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