SOP: Handling of Power Failure in Pharmaceutical Manufacturing Facility

 

1. Purpose

To establish a procedure for managing power failures and ensuring the continued safety, quality, and compliance of pharmaceutical products and systems during such events.

2. Scope

This SOP applies to all manufacturing, packaging, laboratory, warehouse, utility, and quality-related operations at [Company/Site Name].

3. Responsibility

  • Engineering/Utilities: Ensure timely switching to backup (DG/UPS), restore critical utilities, maintain logs.

  • Production / QC / Warehouse: Secure materials/products, equipment, and in-process batches.

  • QA: Evaluate product impact, review deviations, and approve continuation/restart of operations.

  • All Employees: Follow safety procedures during power failure.

4. Procedure

4.1 Immediate Actions

  1. Automatic Backup Activation

    • DG (Diesel Generator) and UPS systems shall switch on automatically.

    • Engineering to monitor activation and record in Power Failure Logbook.

  2. Ongoing Operations

    • Stop manual operations immediately (e.g., weighing, dispensing, compression, filling).

    • Secure equipment in safe mode.

    • Operators must not restart machines until QA clearance is given.

  3. Controlled Areas

    • Doors of cleanrooms to remain closed to maintain integrity.

    • AHU (Air Handling Unit) status to be checked; critical AHUs to run on UPS/DG.

    • If AHUs are off >5 minutes, QA to evaluate environmental control impact.

4.2 Area-wise Instructions

  • Production (Oral / Sterile / Liquid / Ointments):

    • Switch off equipment power supply to avoid sudden surge damage.

    • Segregate and label in-process material as “UNDER EVALUATION”.

    • QA to decide batch continuation/rejection based on risk assessment.

  • QC Laboratory:

    • Save electronic data immediately.

    • Secure ongoing analysis samples.

    • Restart instruments only after stable power supply is restored.

  • Warehouse (RM/PM/FG Stores):

    • Ensure temperature/humidity-controlled stores (cold rooms, refrigerated areas) are on emergency backup.

    • Monitor and record temperature during power failure.

  • Water System:

    • Check if pumps, sanitization heaters, and circulation loops are operational on DG/UPS.

    • QA to review for potential contamination risk if loop is stagnant for >30 min.

  • HVAC Systems:

    • Critical production/classified areas AHUs must run on DG.

    • Non-critical AHUs to be restarted in phased manner to avoid load surge.

4.3 Restoration of Power

  1. Engineering to ensure smooth switching back to main supply.

  2. QA/Engineering to verify critical systems (AHU, water, compressed air, vacuum) before resuming operations.

  3. Production/QC to perform line clearance checks and record restart time.

  4. Batches under processing during failure to be evaluated by QA with documented risk assessment.

4.4 Documentation

  • Record each power failure in Power Failure & Restoration Logbook with:

    • Date & time of failure and restoration.

    • Duration.

    • Systems affected.

    • Immediate actions taken.

    • Batch/area impact.

  • Deviation to be raised if product quality or GMP compliance is suspected to be impacted.

4.5 Preventive Measures

  • Regular preventive maintenance of DG/UPS.

  • Monthly testing of DG auto-start system.

  • Calibration of temperature/humidity monitoring devices.

  • Training of staff on handling power failure scenarios.

5. References

  • EU GMP Part I, Chapter 3 & 5

  • WHO TRS 986 Annex 2 (Utilities & Support Systems)

  • ICH Q9 (Quality Risk Management)

Comments

Post a Comment

Popular Posts