Issue 1: May 2007
PTEye on Quality Assurance:
As a quality professional, your responsibilities are wide-ranging and may include everything from monitoring, analyzing and reporting data, to process analysis, to vendor qualification, to addressing and managing non-conformances. Accomplishing these tasks (and avoiding future citations for your firm!) is an extreme undertaking and demands that quality professionals be well-versed on regulatory requirements, as well have a pulse on current industry trends.
FDA and company expectactions are high and having a thorough knowledge of how to maintain the highest standards of quality is critical to any quality professional. Yet, 7% of the citations issued by FDA in 2006 were traced to inadequate personnel qualifications.
Do you know the leading cause of FDA 483s and Warning Letter citations in FY 2006?
- Personnel qualifications
- Adherence to production procedures
- Batch record review (investigations)
- Laboratory controls
- In-process sampling and testing
(Based on a report issued by Pharmaceutical Technology, December 2006)
May's Newsletter Correct Answer:
c. Batch record review (investigations)
Batch record releases and investigations were only part of the multiple infractions that were traced back to quality departments. This citation was closely followed by citations for shortcomings related to "responsibilities of the quality control unit," thereby proving that the role of a QA professional is a critical piece of maintaining compliance with FDA regulations.
The role of the quality assurance department is to instill confidence that measures are in place to monitor the activities of a company and that those activities conform to predetermined specifications. Ultimately, this goal is realized when the quality assurance department can limit deviations, maintain regulatory compliance, and help ensure customer satisfaction.
*Were you correct??*
Want to get more information about this topic? Click here to view PTi's course, Mastering Your Performance as a QA Professional, which specializes in your needs as a Quality Assurance Professional!
