operating parameters and meets GMP requirements.

2. Scope

This SOP applies to all production equipment and machines installed for use in sterile injectable manufacturing, including filling machines, autoclaves, lyophilizers, mixers, and CIP/SIP systems requiring OQ post-installation or after major maintenance.

3. Responsibilities

• Validation Executive: Preparation and execution of the OQ protocol.
• Engineering Officer: Technical support during qualification activities.
• Quality Assurance (QA): Review and approval of protocols, reports, and deviation management.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that OQ activities are conducted and documented in compliance with regulatory and company standards.

5. Procedure

5.1 Preparation

1. Initiate OQ planning upon completion of IQ (Installation Qualification).
2. Draft the OQ protocol using the standard template approved by QA.
3. Include test parameters, acceptance criteria, test methods, and equipment to be used.
4. Obtain approval of the protocol by QA, Production, and Engineering heads.

5.2 Operational Tests

1. Verify operation of key components such as sensors, actuators, PLCs, alarms, and interlocks.
2. Conduct tests under minimum, nominal, and maximum load conditions where applicable.
3. Record results of:
   • Start/stop functionality
   • Temperature and pressure setpoints
   • Cycle times
   • Safety alarms and error handling
4. Document each test result in the OQ test report (Annexure-1).

5.3 Calibration Verification

1. Verify calibration of all measurement instruments (e.g., temperature sensors, pressure gauges) used during OQ.
2. Calibration certificates should be valid and traceable to national/international standards.

5.4 Software and HMI Checks

1. Verify that HMI displays are functioning correctly and all setpoints are adjustable.
2. Check audit trail functionality and electronic signature integrity if applicable (21 CFR Part 11 compliance).

5.5 Deviation Handling

1. Document any deviations observed during OQ in Annexure-2: Deviation Log.
2. Perform root cause analysis and implement CAPA (Corrective and Preventive Action).
3. Re-test failed parameters after implementation of corrective measures.

5.6 Approval and Documentation

1. Compile all raw data, calibration logs, checklists, and reports into the OQ Summary Report (Annexure-3).
2. QA reviews the report for completeness and compliance.
3. OQ is considered complete only after final approval by QA Head.

6. Abbreviations

• SOP: Standard Operating Procedure
• OQ: Operational Qualification
• IQ: Installation Qualification
• PLC: Programmable Logic Controller
• CAPA: Corrective and Preventive Action

7. Documents

• Annexure-1: OQ Test Report
• Annexure-2: Deviation Log
• Annexure-3: OQ Summary Report

8. References

• WHO TRS 937 Annex 4 – Guidelines on Validation
• ICH Q8, Q9, Q10 Guidelines
• 21 CFR Part 11 – Electronic Records and Electronic Signatures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Validation Executive	QA Executive	Head QA
Department	Engineering	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: OQ Test Report

Test Parameter	Setpoint	Observed Value	Status	Tested By
Temperature (°C)	121	120.9	Pass	Vikram Joshi

Annexure-2: Deviation Log

Date	Deviation	Root Cause	CAPA	Closed By
22/06/2025	Alarm delay	PLC lag	Software patch applied	Rajesh Nair

Annexure-3: OQ Summary Report

Machine ID	Protocol No.	Execution Date	Result	Approved By
AUTO-CLV-03	OQ-2025-118	21/06/2025	Accepted	Priya Kapoor

Revision History

Revision Date	Version	Description	Reason	Approved By
01/01/2022	1.0	Initial issue	New SOP	QA Head
24/06/2025	2.0	Included calibration and deviation handling	Annual Review	QA Head