SOP Guide for Pharma

Elixir Department: SOP for Equipment Verification Before Use – V 2.0

Auditor

Elixir Department: SOP for Equipment Verification Before Use – V 2.0

Standard Operating Procedure for Equipment Verification Before Use in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/068/2025
Supersedes SOP/ELX/068/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standardized procedure for the verification of all equipment used in the manufacturing of elixirs prior to operation, ensuring cleanliness, functionality, calibration status, and readiness for use.

2. Scope

This SOP applies to all manufacturing equipment including mixing tanks, transfer pumps, filtration units, measuring devices, and utility connections used in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Inspect and verify equipment cleanliness, labeling, and utility connections before each batch.
    • Record pre-use checks in the Equipment Verification Log.
  • Production Supervisor:
    • Verify and countersign the equipment readiness check prior to batch initiation.
  • QA Officer:
    • Review equipment verification records and ensure compliance before allowing batch processing to proceed.
See also  Elixir Department: SOP for Minimizing Foaming During Mixing - V 2.0

4. Accountability

The Production Head is accountable for ensuring that only verified and compliant equipment is used during elixir manufacturing operations.

5. Procedure

5.1 Verification

of Cleanliness
  1. Check that the equipment bears a “CLEANED” status label with valid cleaning date and signature.
  2. Visually inspect equipment for any residue, stains, or foreign particles.
  3. Ensure cleaning record is attached or logged in the Equipment Cleaning Record.

5.2 Functional Checks

  1. Check mechanical integrity of moving parts such as agitators, stirrers, and pumps.
  2. Ensure valves, gaskets, and pipe connections are secure and leak-proof.
  3. Test operation of agitators and display panels for normal function.

5.3 Calibration Status

  1. Verify that equipment such as weighing balances, thermometers, pH meters, and flow meters have valid calibration labels.
  2. Ensure calibration is not due or overdue and is traceable to the calibration certificate.
  3. If equipment is found with expired calibration, label as “OUT OF SERVICE” and report to QA and Engineering.

5.4 Utility Verification

  1. Ensure availability of utility services (e.g., compressed air, purified water, steam, electrical supply).
  2. Check pressure and temperature gauges on service lines for expected parameters.
  3. Confirm functionality of exhaust and ventilation systems where applicable.

5.5 Documentation

  1. Complete the Equipment Verification Checklist (Annexure-1) before every batch.
  2. Maintain log entries for each equipment used in the Equipment Verification Logbook (Annexure-2).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice
  • pH: Potential of Hydrogen

7. Documents

  1. Equipment Verification Checklist (Annexure-1)
  2. Equipment Verification Logbook (Annexure-2)
  3. Equipment Calibration Certificate

8. References

  • 21 CFR Part 211.63 – Equipment Design, Size, and Location
  • WHO GMP Guidelines for Pharmaceutical Manufacturing
  • ICH Q7 – GMP for Active Pharmaceutical Ingredients

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 Verification Checklist

Date Equipment Name Cleaned Functional Calibration Valid Verified By
11/04/2025 Mixing Vessel MV-03 Yes Yes Yes Sunita Reddy

Annexure-2: Equipment Verification Logbook

Batch No. Date Equipment ID Operator Supervisor Remarks
ELX-1013 11/04/2025 MV-03 Rajesh Kumar Sunita Reddy All OK

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Issuance New SOP QA Head
11/04/2025 2.0 Included Utility Verification and Log Templates GMP Alignment QA Head
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