SOP Guide for Pharma

Ointments: SOP for Preparing Cleaning Records – V 2.0

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SOP for Preparing Cleaning Records – V 2.0

Procedure for Preparing Cleaning Records

Department Production/Quality Assurance (QA)/Housekeeping
SOP No. SOP/Ointment/153
Supersedes V 1.0
Page No. Page X of Y
Issue Date [Insert Issue Date]
Effective Date [Insert Effective Date]
Review Date [Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for preparing cleaning records in pharmaceutical manufacturing. Cleaning records ensure proper documentation of cleaning procedures performed on equipment, production areas, and storage areas, which is essential for regulatory compliance, product quality, and cross-contamination prevention.

2. Scope

This SOP applies to personnel in the Production, Quality Assurance (QA), and Housekeeping departments responsible for recording, reviewing, and maintaining cleaning records for equipment, production areas, and storage areas.

3. Responsibilities

  • Production Operators: Document cleaning activities for equipment and production areas.
  • Housekeeping Staff: Record routine cleaning and sanitization of manufacturing areas.
  • QA Officer: Cross-verifies records and ensures compliance with documentation standards.
  • QA Manager: Reviews and approves cleaning records before archiving.

4. Accountability

The QA and Production Managers are accountable for ensuring that all cleaning records are maintained in compliance with GMP, FDA, ICH, and WHO regulations.

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5. Procedure

5.1 Types of Cleaning Records

The following types of cleaning records must be maintained:

  • Equipment Cleaning Log: Records details of equipment cleaning, including cleaning agents used, method, and personnel responsible.
  • Area Cleaning Log: Documents cleaning activities for
manufacturing areas, including floors, walls, ceilings, and workstations.
  • Cleaning Validation Record: Maintains validation data confirming cleaning effectiveness.
  • Cleaning Verification Record: Confirms compliance with pre-defined cleanliness standards.

    • 5.2 General Guidelines for Maintaining Cleaning Records

    • All cleaning records must be maintained at the respective cleaning location.
    • Entries must be made in **real time** using indelible ink.
    • Each entry must be signed and dated by the responsible personnel.
    • Cleaning logs must be reviewed periodically by the Production Supervisor and QA team.
    • Logbooks must be bound and paginated sequentially to prevent data tampering.

    5.3 Equipment Cleaning Record Entry Procedure

    • Before starting production, the operator must verify equipment cleanliness.
    • After cleaning, the operator must enter the following details:
      • Date and time of cleaning.
      • Equipment name and identification number.
      • Cleaning method (e.g., wet cleaning, dry cleaning, CIP).
      • Cleaning agents and sanitizers used.
      • Operator’s name and signature.
    • QA personnel must verify and approve the cleaning record before equipment is used.

    5.4 Area Cleaning Record Entry Procedure

    • Housekeeping staff must document cleaning activities daily.
    • The following information must be recorded:
      • Date and time of cleaning.
      • Area cleaned (e.g., production floor, storage room, corridor).
      • Cleaning method used.
      • Cleaning agents and disinfectants applied.
      • Verification signature from QA.

    5.5 Cleaning Validation Record Entry Procedure

    • Validation must be performed at regular intervals.
    • The following details must be recorded:
      • Date of validation test.
      • Equipment or area tested.
      • Validation method (e.g., swab test, rinse test).
      • Acceptance criteria and test results.
      • Verification signature from QA Manager.

    5.6 Review and Approval of Cleaning Records

    • Production Supervisors must review cleaning records weekly.
    • QA must verify logs monthly to ensure compliance.
    • Cleaning validation records must be reviewed quarterly.
    • Cleaning records must be archived securely for at least five years.

    6. Abbreviations

    • GMP – Good Manufacturing Practices
    • QA – Quality Assurance
    • FDA – Food and Drug Administration
    • ICH – International Council for Harmonisation

    7. Documents

    • Equipment Cleaning Log Template (Annexure-1)
    • Area Cleaning Log Template (Annexure-2)

    8. References

    • ICH Q7 – Good Manufacturing Practice Guide
    • WHO Guidelines on Equipment and Facility Cleaning
    • US FDA Guidance on Cleaning Validation

    9. SOP Version

    Version 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Equipment Cleaning Log Template

    Date Equipment Name Cleaning Method Cleaning Agent Used Operator QA Approval
    01/02/2025 Mixing Tank 01 Wet Cleaning IPA 70% John Doe Approved

    Annexure-2: Area Cleaning Log Template

    Date Area Cleaned Cleaning Method Cleaning Agent Used Cleaning Personnel QA Verification
    02/02/2025 Production Floor Mopping Quaternary Ammonium Jane Smith Approved

    12. Revision History

    Revision Date Revision No. Details Reason Approved By
    02/02/2025 2.0 Expanded Procedure Improved Documentation QA Head
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