Scope

This SOP applies to all new, modified, or relocated equipment in the sterile injectable manufacturing area requiring Operational Qualification prior to GMP use, including but not limited to autoclaves, filling machines, lyophilizers, CIP/SIP systems, and isolators.

3. Responsibilities

• Validation Executive: Drafts, executes, and compiles OQ protocols and reports.
• Engineering Department: Supports equipment setup, calibration, and technical configuration.
• Quality Assurance (QA): Reviews and approves qualification documents, and ensures compliance with regulatory standards.

4. Accountability

The Head – Quality Assurance is accountable for the review, approval, and implementation of this SOP and compliance with cGMP requirements.

5. Procedure

5.1 Preparation of OQ Protocol

1. Prepare the OQ protocol following the company’s validation master plan (VMP).
2. The protocol must include:
   • Objective and scope
   • Responsibilities
   • Equipment description with tag number
   • Acceptance criteria
   • Test parameters and frequency
   • Calibration verification
   • Deviation management

5.2 Pre-Qualification Checks

1. Ensure the equipment has completed Installation Qualification (IQ).
2. Verify that calibration of all critical instruments is current.
3. Ensure all utilities (electrical, pneumatic, water, steam) are available and functioning.

5.3 Execution of Operational Qualification

1. Conduct each OQ test as per protocol:
   • Alarm checks for interlocks and safety features
   • Operational cycle tests (start-up, running, shutdown)
   • Speed, temperature, and pressure variation checks
   • HMI/SCADA screen functionality
   • Power failure recovery and restart functions
2. Document results in the OQ data sheets (Annexure-1).

5.4 Deviation Management

1. Record any deviation in Annexure-2: Deviation Log.
2. Initiate deviation form and investigate root cause.
3. Implement corrective and preventive actions (CAPA).

5.5 Approval and Documentation

1. Compile all data sheets, calibration certificates, and results.
2. QA to review and approve the completed OQ Report (Annexure-3).
3. Submit final signed report to validation archive for records.

5.6 Requalification

1. OQ must be repeated when:
   • Major maintenance or repair is performed
   • Software or firmware is upgraded
   • Relocation of equipment occurs

6. Abbreviations

• OQ: Operational Qualification
• IQ: Installation Qualification
• HMI: Human Machine Interface
• SCADA: Supervisory Control and Data Acquisition
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

7. Documents

1. Annexure-1: OQ Data Sheet
2. Annexure-2: Deviation Log
3. Annexure-3: Final OQ Report

8. References

• ICH Q8 – Pharmaceutical Development
• WHO TRS 937 Annex 4 – Validation Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

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	Validation	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: OQ Data Sheet

Parameter	Expected Value	Observed Value	Status	Tested By
Temperature Ramp Up	2°C/min	2.1°C/min	Pass	Ajay Kumar
Cycle Time	30 mins	30 mins	Pass	Ajay Kumar

Annexure-2: Deviation Log

Date	Deviation	Root Cause	CAPA	Approved By
20/06/2025	Temperature overshoot	PID Tuning	Updated PID settings	Sunita Reddy

Annexure-3: Final OQ Report

Equipment ID	OQ Status	Reviewed By	Approval Date
FILLMCH-03	Completed	Rajesh Verma	22/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New equipment qualification	Head QA
24/06/2025	2.0	Added SCADA and CAPA references	Annual review	Head QA