SOP Guide for Pharma

Gel Manufacturing: SOP for Maintaining Equipment Cleaning Logs – V 2.0

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Gel Manufacturing: SOP for Maintaining Equipment Cleaning Logs – V 2.0

Standard Operating Procedure for Maintaining Equipment Cleaning Logs in Gel Manufacturing


Department Gel Manufacturing
SOP No. SOP/GM/133/2025
Supersedes SOP/GM/133/2022
Page No. Page 1 of 10
Issue Date 09/06/2025
Effective Date 11/06/2025
Review Date 09/06/2027

1. Purpose

To describe the procedure for maintaining and documenting equipment cleaning logs for all equipment used in gel manufacturing to ensure traceability, compliance with GMP, and readiness for internal and external audits.

2. Scope

This SOP applies to all manufacturing and cleaning personnel involved in cleaning and documentation of cleaning

activities for all equipment used in the Gel Manufacturing Department.

3. Responsibilities

  • Operators: Perform equipment cleaning and record details in the respective cleaning logbook.
  • Production Supervisor: Verify entries and ensure compliance with documentation practices.
  • QA Executive: Periodically review logbooks for completeness and GMP compliance.
See also  Gel Manufacturing: SOP for Environmental Monitoring in Gel Production Areas - V 2.0

4. Accountability

Head – Manufacturing and Head – Quality Assurance

5. Procedure

5.1 Cleaning Logbook Issuance

  1. QA shall issue a separate cleaning logbook for each equipment with a unique Equipment ID.
  2. The logbook shall be pre-numbered and recorded in the Logbook Issuance Register.

5.2 Log Entry Procedure

  1. Operators shall fill out the cleaning log immediately after cleaning is completed.
  2. Details to be entered include: Date, Time, Equipment Name, Equipment ID, Cleaning Type (Product Changeover/Campaign Cleaning), Product Name, Batch No., Cleaning Method (Manual/CIP), and Signature.
  3. Supervisor shall review the entry and countersign each completed record.

5.3 Record Verification

  1. QA shall verify at least one entry per equipment per week to ensure procedural compliance.
  2. Any discrepancies or missing entries shall be documented and investigated per deviation SOP.
See also  Gel Manufacturing: SOP for Conducting Supplier Audits for Raw Materials - V 2.0

5.4 Logbook Storage and Retention

  1. Completed logbooks shall be collected by QA, closed with remarks, and stored in the documentation archive room.
  2. Retention period: 5 years from date of last entry or as per regulatory requirements.

5.5 Handling of Corrections

  1. Any corrections shall be made with a single line strike-through, initialed, dated, and reason recorded.
  2. Use of correction fluid is strictly prohibited.

6. Abbreviations

  • QA: Quality Assurance
  • CIP: Clean-In-Place
  • GMP: Good Manufacturing Practices

7. Documents

  1. Equipment Cleaning Logbook – Annexure-1
  2. Logbook Issuance Register
  3. Deviation Report (if applicable)

8. References

  • Schedule M – Good Manufacturing Practices
  • WHO TRS 986 – GMP Guidelines for Documentation
  • 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
See also  Gel Manufacturing: SOP for Cleaning and Disinfection of Manufacturing Areas - V 2.0

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: Equipment Cleaning Log Format

Date Equipment Name Equipment ID Cleaning Type Product Name Batch No. Cleaning Method Performed By Reviewed By

Revision History

Revision Date Revision No. Change Description Reason Approved By
01/05/2022 1.0 Initial Issue New SOP QA Head
09/06/2025 2.0 Updated log format and sampling frequency Annual Review QA Head
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