production equipment including vial fillers, syringe fillers, autoclaves, lyophilizers, and cleanroom utilities that may be affected by unexpected power interruptions within sterile manufacturing facilities.

3. Responsibilities

• Machine Operator: Immediately stop operations and inform engineering and QA personnel.
• Engineering Officer: Investigate and restore power supply, perform equipment checks.
• QA Officer: Assess the impact on product quality, decide on batch status post-power recovery.
• Shift Supervisor: Coordinate communications, document incident, and oversee restart activities.

4. Accountability

The Head of Production is accountable for ensuring all operations comply with this SOP during and after a power failure, and for reporting deviations to Quality Assurance.

5. Procedure

5.1 Identification of Power Failure

1. Monitor alarm indicators, HMI blackout, or control panel inactivity to confirm power loss.
2. Check other equipment and lighting in the production area to assess the extent of failure.
3. Log the time of power failure initiation in the machine downtime record (Annexure-1).

5.2 Immediate Actions

1. Halt any ongoing operations and ensure personnel safety by withdrawing from electrical interfaces.
2. Secure all open containers, vials, and critical WIP (Work In Progress) under laminar flow hoods or seal containers if possible.
3. Notify Engineering and QA teams promptly.
4. Power down machines using E-Stop (emergency stop) if not already off to avoid sudden surges when power is restored.

5.3 Equipment Safety Checks Post-Restoration

1. Upon restoration, Engineering must verify:
   • Main supply voltage is stable and within safe operational range.
   • No signs of short circuits, motor damage, or abnormal noise/vibration.
2. Document power restoration time and engineer’s inspection summary in Annexure-1 and Annexure-2.

5.4 Resuming Operations

1. QA must assess product status (intermediate or filled units) during power loss.
2. If the batch is under process:
   • Inspect environmental conditions and validate they remained within specifications.
   • Conduct in-process checks for fill weight, temperature, sterility zone compliance, etc.
   • QA to provide go/no-go decision documented in Annexure-3.
3. Production may resume only after written clearance from QA and Engineering.

5.5 Documentation

1. Fill in power failure event log (Annexure-1) and equipment inspection checklist (Annexure-2).
2. QA shall complete post-power failure batch disposition form (Annexure-3).

5.6 Preventive Measures

1. Ensure UPS (Uninterrupted Power Supply) is active for HMI and control units.
2. Perform generator checks weekly and record in utility readiness log.
3. Train production teams every 6 months on power failure response protocol.

6. Abbreviations

• SOP: Standard Operating Procedure
• HMI: Human Machine Interface
• QA: Quality Assurance
• UPS: Uninterrupted Power Supply

7. Documents

1. Machine Downtime Record – Annexure-1
2. Equipment Post-Power-Check Report – Annexure-2
3. Batch Disposition Form Post-Power Failure – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• ICH Q9 – Quality Risk Management
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Machine Downtime Record

Date	Machine ID	Time of Failure	Time Restored	Operator	Remarks
18/06/2025	INJ-FILL-03	10:20 AM	10:45 AM	Ajay Sharma	Power fluctuation

Annexure-2: Equipment Post-Power-Check Report

Machine ID	Inspection Date	Inspected By	Outcome	Remarks
INJ-FILL-03	18/06/2025	Sunil Patil	No Damage	Ready for use

Annexure-3: Batch Disposition Form Post-Power Failure

Batch No.	Product	Stage at Interruption	QA Review Outcome	Decision	QA Reviewer
INJ/B23/079	Amikacin Injection	Filling in Progress	Within Specifications	Continue Processing	Meena Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
18/06/2025	2.0	Added equipment inspection and disposition forms	Annual Review	QA Head