process equipment, vessels, filling lines, cleanroom areas, and accessories used in sterile injectable manufacturing at [Facility Name].

3. Responsibilities

• Production Department: Performs cleaning and informs QA for verification.
• Quality Assurance: Conducts swab and rinse sampling, reviews cleaning records, approves the equipment for next use.
• Microbiology Lab: Analyzes microbial bioburden and endotoxin results as required.

4. Accountability

Head QA shall be accountable for ensuring adherence to this SOP and for release of cleaned equipment for reuse based on verification results.

5. Procedure

5.1 Types of Cleaning Verification

• Visual Inspection: Conducted after every cleaning activity.
• Analytical Verification: Conducted at defined frequency or product changeover using validated methods.
• Microbiological Verification: Conducted in aseptic areas using swab and contact plate testing.

5.2 Visual Inspection

1. Inspect all product contact surfaces using white light and UV lamp (if applicable).
2. Ensure absence of visible residue, stains, rust, or moisture.
3. Document findings in the Equipment Cleaning Log (Annexure-1).

5.3 Analytical Swab/Rinse Sampling

1. Identify worst-case locations for swab sampling based on equipment design.
2. Use pre-validated swabbing method and materials (Annexure-2).
3. Collect rinse samples if equipment allows circulation/flush system.
4. Submit samples to QC for analysis of product residue, cleaning agent residue (e.g., NaOH), or API traces.
5. Results must comply with acceptance criteria defined in the cleaning validation protocol.

5.4 Microbiological Verification

1. Collect surface swab samples and contact plates from cleanroom surfaces and critical equipment post-cleaning.
2. Send samples to microbiology lab for analysis within 2 hours of collection.
3. Acceptance criteria:
   • Grade A: <1 CFU
   • Grade B: ≤5 CFU
   • Grade C: ≤50 CFU
   • Grade D: ≤100 CFU

5.5 Review and Approval

1. QA reviews all verification results including analytical and microbiological reports.
2. If results are within limits, equipment is approved for reuse using Equipment Release Form (Annexure-3).
3. If OOS (Out of Specification) results are found, initiate deviation and re-cleaning as per SOP.

5.6 Frequency of Cleaning Verification

• After each batch for dedicated equipment.
• At batch/product changeover for multipurpose equipment.
• Monthly verification for high-risk product lines.

6. Abbreviations

• SOP: Standard Operating Procedure
• CFU: Colony Forming Unit
• OOS: Out of Specification
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Equipment Cleaning Log – Annexure-1
2. Swab Sampling Format – Annexure-2
3. Equipment Release Form – Annexure-3

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS 1010 Annex 3 – GMP for Sterile Pharmaceutical Products
• 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	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Equipment Cleaning Log

Date	Equipment ID	Cleaned By	Verified By
17/06/2025	SV-1201	Sunita Reddy	Ravi Chauhan

Annexure-2: Swab Sampling Format

Date	Equipment ID	Swab Location	Sampler	Sample ID
17/06/2025	MLF-303	Outlet Valve	Anjali Mehta	SWB203

Annexure-3: Equipment Release Form

Equipment ID	Cleaning Verified	Released By	Date
MLF-303	Yes	Kiran Deshmukh	17/06/2025

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial issue	New SOP	QA Head
18/06/2025	2.0	Updated verification limits and added analytical section	Annual Review	QA Head