| Quality Systems
One of Cedarburg's core strengths is our commitment to quality assurance and quality control. We undergo continual cGMP training and have an excellent track record with the FDA. Our most recent successful pre-approval inspection (PAI) was conducted in 2006. Our staff ensures excellence from start to finish.
As a result of our strong Quality Systems group and our management's strong belief in compliance, our most recent PAI inspections were completed without any 483 being issued (last PAI inspection May 2004).
Our Quality Systems personnel operate an extensive amount of analytical equipment including GC-MS, Agilent 1100 HPLCs, Agilent GCs with headspace capability, and IR, UV, Ion Chromatograph, and polarimetry also available.
We have established a quality control program that provides for:
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Raw material qualifications and sample retain |
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Final product release and retain |
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Method validation/verification |
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Metrology |
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IQ/OQ, instrument calibration/performance verification |
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Failure investigations |
All staff members at Cedarburg participate in a continuous training program to ensure they perform in compliance with our most current procedures.
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