Standard Operating Procedure for Cleaning and Disinfection of Sampling Tools in Quarantine
| Department | Quality Control / Quality Assurance / Warehouse |
|---|---|
| SOP No. | SOP/RM/081/2025 |
| Supersedes | SOP/RM/081/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for the cleaning and disinfection of sampling tools used in the quarantine area. This ensures the prevention of cross-contamination and maintenance of sample integrity, in compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel responsible for using, cleaning, and disinfecting sampling tools such as scoops, sampling thieves, pipettes, and containers used for raw material sampling in the quarantine area.
3. Responsibilities
- Quality Control (QC) Personnel: Perform cleaning and disinfection procedures, and maintain cleaning records.
- Warehouse Personnel: Assist in ensuring tools are transported to the designated cleaning areas and stored properly post-cleaning.
- Quality Assurance (QA): Review and verify compliance with cleaning protocols, and approve cleaning records.
4. Accountability
The QC Manager is responsible for ensuring proper cleaning and disinfection procedures are followed. The QA Manager ensures compliance with SOP and regulatory requirements, and the Warehouse
Manager ensures proper storage of cleaned tools.
5. Procedure
5.1 General Cleaning Guidelines
- Designated Cleaning Area:
- All cleaning and disinfection must be carried out in a designated, controlled environment to prevent contamination.
- Ensure that cleaning materials and disinfectants are approved by QA.
- Personal Protective Equipment (PPE):
- Personnel must wear appropriate PPE, including gloves, lab coats, face masks, and goggles.
5.2 Cleaning Procedure
- Pre-Cleaning Inspection:
- Inspect sampling tools for visible contamination or damage.
- Document the inspection in the Tool Inspection Log (Annexure-1).
- Manual Cleaning Process:
- Disassemble tools (if applicable) for thorough cleaning.
- Rinse tools with deionized water to remove loose particles.
- Clean tools using an approved detergent solution and soft brushes to remove residues.
- Rinse thoroughly with deionized water to ensure no detergent residue remains.
- Drying:
- Dry tools using lint-free wipes or allow to air dry in a clean environment.
5.3 Disinfection Procedure
- Approved Disinfectants:
- Use only QA-approved disinfectants (e.g., 70% isopropyl alcohol, hydrogen peroxide solutions).
- Ensure the disinfectant is compatible with the material of the sampling tools.
- Disinfection Steps:
- Apply the disinfectant to all surfaces of the cleaned tools using sterile wipes or by immersion (if applicable).
- Allow the disinfectant to contact the surfaces for the required dwell time (as per disinfectant manufacturer instructions).
- Rinse tools with sterile deionized water if required by the disinfectant instructions.
- Post-Disinfection Handling:
- Transfer tools to a sterile drying area and allow them to dry completely.
- Document the disinfection process in the Cleaning and Disinfection Log (Annexure-2).
5.4 Storage of Cleaned Tools
- Storage Conditions:
- Store cleaned and disinfected tools in designated, labeled storage cabinets or sterile containers.
- Ensure tools are protected from dust, moisture, and other contaminants.
- Storage Documentation:
- Document the storage location and status of tools in the Tool Storage Log (Annexure-3).
5.5 Handling Deviations in Cleaning and Disinfection
- Deviation Reporting:
- Report any deviations from the cleaning procedure to the QA Manager.
- Document deviations in the Cleaning Deviation Report (Annexure-4).
- Corrective Actions:
- Investigate and rectify the root cause of the deviation.
- Document corrective actions in the Corrective Action Log (Annexure-5).
5.6 Training and Compliance
- Personnel Training:
- All personnel must be trained in the proper cleaning and disinfection procedures before handling sampling tools.
- Document training in the Training Log (Annexure-6).
- Compliance Monitoring:
- QA must conduct regular audits to ensure adherence to cleaning protocols.
- Document audit findings in the Compliance Audit Log (Annexure-7).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- PPE: Personal Protective Equipment
7. Documents
- Tool Inspection Log (Annexure-1)
- Cleaning and Disinfection Log (Annexure-2)
- Tool Storage Log (Annexure-3)
- Cleaning Deviation Report (Annexure-4)
- Corrective Action Log (Annexure-5)
- Training Log (Annexure-6)
- Compliance Audit Log (Annexure-7)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- EU Guidelines on Good Distribution Practices (GDP)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Tool Inspection Log
| Date | Tool Name | Condition | Inspected By | Remarks |
|---|---|---|---|---|
| 01/02/2025 | Sampling Thief | No Visible Damage | Ravi Kumar | Ready for Cleaning |
Annexure-2: Cleaning and Disinfection Log
| Date | Tool Name | Cleaning Method | Disinfectant Used | Cleaned By | Verified By (QA) |
|---|---|---|---|---|---|
| 01/02/2025 | Sampling Thief | Manual Wash | 70% Isopropyl Alcohol | Sunita Sharma | Anjali Mehta |
Annexure-3: Tool Storage Log
| Date | Tool Name | Storage Location | Stored By | Verified By (QA) |
|---|---|---|---|---|
| 01/02/2025 | Sampling Thief | Sterile Cabinet A | Ajay Singh | Anjali Mehta |
Annexure-4: Cleaning Deviation Report
| Date | Tool Name | Deviation Description | Reported By |
|---|---|---|---|
| 02/02/2025 | Sampling Thief | Missed Disinfection Step | Ravi Kumar |
Annexure-5: Corrective Action Log
| Date | Deviation Description | Corrective Action | Implemented By | Verified By (QA) |
|---|---|---|---|---|
| 03/02/2025 | Missed Disinfection Step | Re-cleaned and Disinfected | Ajay Singh | Anjali Mehta |
Annexure-6: Training Log
| Date | Training Topic | Trainer | Attendee Name | Signature |
|---|---|---|---|---|
| 04/02/2025 | Cleaning and Disinfection Procedures | Health & Safety Officer | Sunita Sharma |
Annexure-7: Compliance Audit Log
| Date | Audit Type | Findings | Corrective Actions Taken | Audited By |
|---|---|---|---|---|
| 05/02/2025 | Cleaning Compliance | Incomplete Documentation | Updated Cleaning Logs | Anjali Mehta |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated Cleaning and Disinfection Procedures | Regulatory Compliance | QA Head |