FDA recently cited a firm for failing to establish and follow written procedures for the cleaning and maintenance of equipment and utensils.
The specific findings in this case highlight three critical areas of neglect:
- Calibration Overdue by 18 Months: A Total Organic Carbon (TOC) analyzer used for testing the water system was found to be nearly a year and a half past its recalibration date.
- Missing Thermometer Records: There were no calibration records to prove that thermometers used for verifying in-process temperatures were accurate.
- Documentation Discrepancies: While a batch record indicated a scale accuracy check was performed, the dedicated “Scale Check Log” had no entry for that day, violating the firm’s own SOP for “Formulation Process Control.”
This failure is in violation of 21 CFR 211.67(a), which mandates that equipment be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination.
When maintenance schedules are ignored or documentation is inconsistent, it suggests a broader failure to follow established SOP’s. Without validated calibration and maintenance, there is no scientific justification to prove that the equipment is functioning correctly, which can lead to significant quality risks.
To avoid similar citations, firms must ensure their quality systems address the following:
- Strict Adherence to Schedules: Maintenance and calibration intervals must be established and strictly followed.
- Robust Documentation: Discrepancies between batch records and equipment logs indicate weak oversight and poor documentation practices.
- Detailed SOPs: Procedures must be specific and complete.
According to our GMP Trends Annual Reports, over the last 9 years the observations pertaining to equipment cleaning (21 CFR 211.67(a), and 21 CFR 211.67(b)) have been in the top 10 observations cited by the FDA each year.
The following are references from FDA pertaining to cleaning validation guidance:
