to all cleaning validation activities performed on manufacturing equipment such as mixing vessels, storage tanks, homogenizers, deaerators, filling machines, and pipelines used in gel manufacturing processes at the facility.

3. Responsibilities

• Production Department: Execution of cleaning procedures and sampling as per protocol.
• Quality Assurance (QA): Preparation and approval of validation protocols and reports.
• Quality Control (QC): Analysis of swab and rinse samples for chemical and microbial testing.
• Engineering Department: Maintenance of equipment cleanliness and calibration of cleaning devices.

4. Accountability

Head of Quality Assurance is accountable for final review and approval of cleaning validation activities and associated documentation.

5. Procedure

5.1 Preparation

1. QA prepares a Cleaning Validation Protocol (Annexure-1) including:
   • Objective and scope
   • Equipment list
   • Acceptance criteria
   • Sampling plan and analytical methods
   • Worst-case product selection
2. Protocol is reviewed and approved by QA, QC, Production, and Engineering.

5.2 Execution

1. Equipment is cleaned using the standard procedure outlined in relevant SOPs.
2. After cleaning, allow equipment to dry (if applicable).
3. Swab and rinse samples are collected by QC as per the sampling plan (Annexure-2).
4. Ensure sampling is done from worst-case locations: dead legs, weld seams, gaskets, etc.

5.3 Analysis

1. Swab and rinse samples are analyzed by QC for:
   • Residue of previous product (active ingredient)
   • Cleaning agent residues
   • Total microbial count
   • Specific pathogens (e.g., E. coli, Salmonella)
2. Acceptance criteria:
   • Residue levels should be below defined Maximum Allowable Carryover (MACO)
   • No detectable levels of cleaning agents
   • Microbial counts within acceptable limits

5.4 Documentation

1. All test results, observations, and deviations (if any) are recorded in the Cleaning Validation Report (Annexure-3).
2. Final report is reviewed by QA and approved by the QA Head.
3. All documentation is archived as per the Document Control SOP.

5.5 Revalidation

1. Revalidation is required if:
   • There is a change in cleaning procedure
   • Change in product or equipment
   • Major maintenance or repair
   • Periodic revalidation schedule is due (typically every 3 years)

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• MACO: Maximum Allowable Carryover
• cGMP: current Good Manufacturing Practice

7. Documents

1. Cleaning Validation Protocol – Annexure-1
2. Swab and Rinse Sample Log – Annexure-2
3. Cleaning Validation Report – Annexure-3

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Cleaning Validation
• EU GMP Annex 15: Qualification and Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Cleaning Validation Protocol

Protocol No.
Equipment Name/ID
Product Name
Cleaning Procedure Reference
Sampling Locations
Analytical Methods
MACO Limits

Annexure-2: Swab and Rinse Sample Log

Sample Type	Location	Date	Collected By	Received By (QC)
Swab
Rinse

Annexure-3: Cleaning Validation Report

Report No.
Equipment ID
Batch No.
Residue Test Results
Cleaning Agent Residues
Microbial Test Results
Conclusion
Approved By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial release	New SOP	QA Head
02/06/2025	2.0	Updated format and annexures	Periodic Review	QA Head