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.

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

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

5.2 Functional Checks

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

5.3 Calibration Status

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

5.4 Utility Verification

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

5.5 Documentation

Complete the Equipment Verification Checklist (Annexure-1) before every batch.
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

Equipment Verification Checklist (Annexure-1)
Equipment Verification Logbook (Annexure-2)
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