Top Maintenance Trends in FDA Inspections

The FDA is displaying heightened interest in maintenance and asset management during inspections.  Along with the future adoption of ISO 55000 scheduled for February 2014, there is a strong focus on asset management and a drive toward risk-based maintenance standards in the pharmaceutical and biotech industries.  

In August 2013, Blue Mountain polled Society for Maintenance and Reliability Professional’s discussion group (SMRP’s Pharmaceutical and Biotech Special Interest Group) to identify – from active industry practitioners – the top maintenance trends seen in recent in FDA inspections.  The major trends include:

  • Increasing inspections of critical utilities – Beyond manufacturing equipment, FDA inspectors are analyzing the manufacturing environment in more detail with special attention on critical utilities. They are looking at maintenance work orders and preventive maintenance records involving water systems, air systems, etc. to ensure that the plant is “saying what they do and doing what they say” and, of course, meeting all GMP compliance.
  • Increasing demand for emergency maintenance documentation and QA – Another significant trend in FDA inspections is the analysis of emergency maintenance documentation and the parts used. The FDA is investigating proper documentation of spare parts (like-for-like qualification). Like-for-like parts should be supported with evidence. In addition, unscheduled work orders often lead to a lack of proper documentation, supervisor review and calibration adjustments. The FDA is focused on identifying areas of fault within unscheduled work orders.
  • Reviewing of recent audits – Significantly, our discussion group suggested that in FDA, ISO and other assessments, inspectors are reviewing recent internal and external company audits and looking for a clearly defined corrective action plan.  The inspectors are looking for warnings in these previous audits and how the company has since addressed them. Corrective maintenance follow-up is becoming more and more crucial to satisfying FDA requests. 
  • Challenging calibration ranges and standards – We had conflicting opinions in our discussion on this trend.  Some participants claimed that inspections of calibration ranges and standards are a function of non-regulatory audits rather than FDA inspections. Despite these differing views, it appears that there is some FDA examination of defined calibration ranges, standards and accuracy of equipment. The FDA is looking for properly maintained equipment, accurate calibration results and properly set calibration ranges – in other words, clearly defined calibration management.
  • Inspecting computer systems and processes to ensure compliance – The final trend that we witnessed is the inspection of computer systems and processes. Implementing and utilizing a CMMS, CCMS, EAM system can prevent warnings letters by providing/storing all of the necessary documentation for the company and ensuring the company meets 21 CFR Part 11 compliance. Auditors often look for properly implemented asset management systems and their utilization within the company.

Are these maintenance trends in FDA inspections reflected in your company? What other trends are you experiencing in regards to maintenance in FDA audits?

To learn more about pharmaceutical and biotech maintenance inspection trends, check out our upcoming webinar  The Impact of FDA Trends on Maintenance.

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