Do Not Conduct Repairs During Batch Production in GMP Facilities

Avoid Conducting Equipment Repairs During Active Batch Processing

Remember: Do not perform any maintenance or repairs on equipment or systems during batch processing without risk assessment and QA approval.

Why This Matters in GMP

Repairs during ongoing batch production introduce uncontrolled elements into a validated process, increasing the risk of contamination, mix-ups, or equipment failure. This practice may disturb product flow, violate cleanroom protocols, or introduce foreign particles or lubricants. GMP emphasizes process integrity and consistency—any unplanned intervention during batch manufacturing can compromise both. Immediate repairs without a documented risk assessment can invalidate process controls and require batch rejection. Therefore, all repairs must be deferred until batch completion or conducted with formal deviation management and quality oversight.

Also Read: Preventing Cross-Contamination in Sterile Product Manufacturing

Regulatory and Compliance Implications

FDA 21 CFR Part 211.67 and 211.100 highlight the need for proper equipment maintenance and written procedures for deviations. WHO GMP and EU GMP Chapter 5 advise against interventions during production without justified risk mitigation. Schedule M stresses clean and uninterrupted operations during active processing. Auditors examine maintenance records, deviation reports, and QA decisions involving in-process repairs. Failure to manage such interventions can result in 483 observations or batch rejection during regulatory review. Facilities must demonstrate that repair actions are controlled and do not compromise GMP product quality.

Implementation Best Practices

Schedule maintenance and repair activities between production campaigns or after batch completion.
If urgent repair is needed, initiate deviation handling with QA approval and documented risk assessment.
Conduct line clearance and area cleaning before resuming manufacturing activities.
Maintain maintenance logs with batch numbers affected and QA decisions documented.
Train engineering and production staff on repair restrictions during live batch processing.

Also Read: Document Operator Training for Each Product Line to Ensure GMP Compliance

Regulatory References

FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
FDA 21 CFR Part 211.100 – Written Procedures; Deviations
EU GMP Chapter 5 – Production
WHO GMP – Equipment Maintenance and Batch Continuity
Schedule M – Maintenance and Deviation Control