(cGMP), WHO, and ICH guidelines.

2. Scope

This SOP applies to all high-pressure pumps used in solution preparation and transfer during the sterile injectable manufacturing process at the facility. It includes new pumps, modified equipment, and routine re-validation.

3. Responsibilities

• Production Executive: Executes cleaning as per defined procedure.
• Quality Control (QC): Collects and tests samples for chemical and microbial analysis.
• Validation Team: Prepares and executes cleaning validation protocol.
• Quality Assurance (QA): Reviews and approves validation documents.

4. Accountability

The Head of Quality Assurance is accountable for ensuring compliance with this SOP and overall cleaning validation requirements for high-pressure pumps.

5. Procedure

5.1 Preparation

1. Ensure the equipment is identified and tagged for cleaning validation.
2. Verify the cleaning procedure and batch record are approved and up to date.
3. Gather required documentation: cleaning validation protocol, sampling plan, and logbooks.

5.2 Cleaning Procedure

1. Ensure the pump is disconnected from the process line and power is isolated.
2. Disassemble the pump (head, diaphragm, seals) using approved tools and PPE.
3. Clean each part with approved cleaning agent (e.g., 1% NaOH or validated detergent solution).
4. Rinse thoroughly with Purified Water (PW) and follow up with Water for Injection (WFI).
5. Inspect visually for any residues. Record findings in Annexure-1.

5.3 Sampling

1. After cleaning and before reassembly, collect:
   • Swab samples from critical contact surfaces (e.g., diaphragm, outlet port)
   • Rinse samples from final rinse WFI
2. Label samples clearly with equipment ID, date, and sampled location.
3. Deliver to QC within 2 hours of sampling.

5.4 Testing and Acceptance Criteria

1. QC shall analyze samples for:
   • Chemical residue (UV, TOC, or HPLC as applicable)
   • Microbial contamination (bioburden test)
2. Acceptance criteria:
   • Residue: <10 ppm (as per product-specific limit)
   • Microbial count: <1 cfu/cm² (for swabs), <10 cfu/100 ml (for rinse)
3. Record results in Annexure-2.

5.5 Documentation and Approval

1. Compile all test data, cleaning checklist, deviation reports (if any), and sample records into the Cleaning Validation Report (Annexure-3).
2. QA shall review and sign off on the report.
3. Archive report in the Validation Document Room for a minimum of 5 years.

5.6 Re-validation Criteria

1. Re-validation shall be conducted when:
   • New product introduced
   • Pump design modified
   • Cleaning process or agents changed
   • Failure to meet acceptance in routine checks

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• WFI: Water for Injection
• TOC: Total Organic Carbon
• cfu: Colony Forming Units

7. Documents

1. Annexure-1: Cleaning Checklist
2. Annexure-2: Analytical Report
3. Annexure-3: Cleaning Validation Report

8. References

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS 961 Annex 4: Cleaning validation
• 21 CFR Part 211.67: Equipment Cleaning and Maintenance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Validation Executive	QA Executive	Head QA
Department	Validation	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Cleaning Checklist

Step	Done By	Date	Remarks
Disassembly of Pump	Rajesh Kumar	20/06/2025	OK
Initial Rinse with PW	Rajesh Kumar	20/06/2025	OK
Detergent Wash	Rajesh Kumar	20/06/2025	No Residue

Annexure-2: Analytical Report

Sample Type	Location	Residue (ppm)	Bioburden (cfu)	Status	Tested By
Swab	Outlet Port	5.3	0	Pass	Sunita Reddy
Rinse	Final WFI	3.0	2	Pass	Sunita Reddy

Annexure-3: Cleaning Validation Report

Pump ID	Product Name	Validation Status	Reviewed By	Date
HP-PUMP-002	IV Solution A	Completed	Vikram Singh	22/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Added Annexures and acceptance criteria	Annual Review	QA Head