A recent FDA inspection identified a critical failure in the internal audit program regarding auditor independence. The observation centers on noncompliance with the SOP for internal audits, which requires auditors to be independent from the departments they are evaluating. The 483 reads as follows:
…..Individuals who conduct quality audits have direct responsibility for the matters being audited.
Specifically, your procedure, SOP …,“Internal audit” procedure requires that internal auditors be independent of departments other than the one under which they belong. Your firm’s internal audit report performed last year, shows that internal auditors with job titles: Quality Management, Quality Assurance, and Regulatory Affairs performed an audit of your quality management (QC & QA) department. Your firm’s auditors were not independent of departments other than the one under which they belong, as required by your procedure.
Honesty and authenticity is paramount for internal audits. Without auditor independence, the value of internal audits as a tool in your quality system is diluted, potentially allowing noncompliance actions to continue. Catching mistakes before FDA does is the difference between negative patient outcomes, hiring consultants, and having to navigate bad press in the industry.
Throughout our 47 years of service, we have continuously heard about our customers’ utilization of our GMP Trends Reports to guide internal audits. Every two weeks we publish a new GMP Trends Report, where we trend recent 483’s by topic. Our reports are a fantastic radar about the ebbs and flows of FDA inspection trends, ensuring you stay consistent with reading and learning from 483’s. If you would like us to send you a sample GMP Trends Report, please email [email protected].
Our FDA Inspection Database contains complete site inspection histories, FDA Investigator Profiles, and a 483 Database. Schedule a call to save your quality team time and resources through easy access to powerful data. Book a call with the link here.
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