For organizations in the life sciences, equipment maintenance plays a critical role in ensuring that products are pure, effective, and safe. When assets aren’t correctly maintained, product quality can suffer — and so can regulatory compliance.
Food and Drug Administration (FDA) inspectors scrutinize maintenance operations during every audit, seeking proof that MRO teams are following a documented preventive maintenance and calibration plan. Deficiencies in these areas can lead to Form 483 citations and, eventually, to warning letters and penalties.
We’ll talk about the most common FDA audit findings and dig into some best practices for staying compliant. We’ll also explore how computerized maintenance management software (CMMS) can help.
What are the FDA regulations governing equipment maintenance?
The FDA’s Good Manufacturing Practice (GMP) regulations are detailed in Title 21 of the Code of Federal Regulations (21 CFR).
21 CFR Part 211 lists the requirements for cleaning, maintaining, and calibrating manufacturing equipment. Other sections in 21 CFR describe industry-specific maintenance regulations; for example, Part 820 sets out the maintenance requirements for medical device manufacturers.
The regulations emphasize preventive and proactive maintenance, thorough training for all employees, and rigorous documentation of all maintenance activities. Failing to adhere to any of those requirements can result in warning letters.
Here are some of the most common FDA audit findings with regard to equipment maintenance.
Documentation issues
The FDA requires GMP organizations to document maintenance and calibration procedures at every stage. Inspectors expect a detailed written plan for equipment maintenance and monitoring to ensure that manufacturing equipment produces consistent products that are uncontaminated.
Any changes to the existing maintenance plan must be thoroughly documented and approved, and those documents must be available for inspection. Maintenance, calibration, and cleaning tasks must also be logged in the correct format.
FDA audits often flag organizations for documentation issues, especially inadequate standard operating procedures (SOPs), incomplete logbooks, or failure to follow procedures.
For busy MRO teams, the FDA’s documentation requirements can feel overwhelming. Digital tools, like a good CMMS, make this process pain-free by automating the tracking and recording of preventive maintenance and calibration tasks.
Failure to qualify equipment
Equipment qualification, a requirement for all GMP organizations, is a documented protocol demonstrating that production equipment is properly installed and consistently performs according to expectations. FDA inspectors expect to see detailed written SOPs for equipment qualification documented at four key stages:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
The purpose is to ensure that manufacturing equipment is carefully selected, installed, and maintained throughout its lifecycle, so that it consistently produces high-quality products.
Failing to adequately qualify equipment is a common FDA finding. Fortunately, the right tools and strategies can help you prevent this issue (or correct it if necessary). A CMMS plans, schedules, and tracks equipment qualification workflows, so you can easily demonstrate compliance.
Failure to adequately clean, sanitize, and sterilize production equipment
21 CFR requires pharmaceutical manufacturers to clean, maintain, and, as appropriate, sanitize or sterilize equipment and tools at regular intervals to prevent malfunctions or contamination.
During FDA inspections, auditors check whether facilities and equipment are clean and sterile. Inspectors also want to see that maintenance teams have a clear and detailed cleaning validation process. A cleaning validation is a documented study demonstrating that the existing cleaning and sanitization workflows are effective at removing residues and contaminants from production equipment.
Briefly: to avoid a citation or warning letter, maintenance teams must regularly clean, sanitize, and sterilize all manufacturing facilities and equipment using a validated SOP. They must also keep logbooks tracking their cleaning workflows. Note that inspectors often prefer digital logbooks, since they are easier to transport and review off-site.
Inadequate facility maintenance
21 CFR mandates that production facilities be regularly cleaned, sanitized, and sterilized. Inspectors expect to see documentation proving a clear SOP is in place for cleaning the facility and that teams are consistently following this procedure.
If the facility includes a cleanroom, inspectors will check to ensure that it is free of contamination and is regularly maintained. They may want to see records of smoke studies or tests showing that the air in the cleanroom moves in a unidirectional manner.
FDA inspectors often cite companies for failing to maintain stringent environmental standards and provide documentation — including smoke studies — to verify compliance.
Failure to implement appropriate corrective and preventive action (CAPA)
The FDA requires organizations to thoroughly investigate any unexplained discrepancy or batch failure, and to implement an appropriate plan for corrective and preventive action, or CAPA. Manufacturers are required to document their investigation of the issue and create a plan to prevent recurrence.
For maintenance teams, this means conducting root cause analysis (RCA), making all necessary repairs, and recalibrating equipment as needed. It also involves creating a preventive maintenance plan to prevent future occurrences.
CAPA is a leading cause of FDA audit findings, often leading to Form 483 citations and warning letters. Staying ahead of CAPA citations is usually a matter of careful planning and resource allocation; managers need to ensure they implement a structured preventive maintenance plan that addresses any recent production failures.
Insufficient staff training
GMP organizations must ensure that every employee is fully trained for their specialized role. The FDA sees training as an ongoing process and emphasizes the need to retrain teams whenever SOPs or regulations change.
Inspectors will check to see whether each employee has the appropriate, up-to-date certifications; they will also look for records of ongoing training sessions. The FDA wants to see that the training is thorough and conducted by qualified instructors.
Failing to adequately train employees is a leading cause of FDA citations and warnings. Companies also receive warnings when they don’t have adequate documentation of staff training sessions.
At a glance: FDA audit findings
FDA citations and warning letters often focus on the following issues:
- Lack of correct documentation
- Failure to qualify equipment
- Inadequate cleaning of equipment
- Improper facility maintenance
- Lack of corrective and preventive maintenance
- Insufficient employee training
Best practices for compliance: How eMaint CMMS can help
Maintaining regulatory compliance requires meticulous documentation and a detailed, proactive maintenance strategy. eMaint CMMS helps with both.
eMaint tracks and stores asset data from work orders, maintenance records, and IoT sensors, making it easier to plan a targeted preventive maintenance strategy. eMaint can even schedule preventive maintenance and calibration tasks, log them, and store the data on audit dashboards.
Robust eMaint reporting functions let you document and demonstrate equipment qualification workflows, as well as cleaning and calibration. Automated notifications mean tasks don’t slip through the cracks. eMaint can even track and plan employee certification and training sessions — and smart scheduling features ensure that the right employees are always assigned to a task.
Pharmaceutical manufacturers bear a heavy responsibility to the public and to regulators. eMaint gives you the support you need to take the stress out of compliance — so you can focus on delivering the very best products to your customers.