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January 28, 2020
A common question when transferring an established process from one facility to another is how to establish that the transferred process is performing equivalently to the original process. Sounds...
October 8, 2015
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
April 2, 2015
Trying to remain compliant with the current Good Manufacturing Practices (cGMP) has its challenges and opportunities. I would like to discuss the opportunity afforded by the ASTM E2500 "Standard...
March 12, 2015
Moving an operational Quality Control Laboratory is all about maintaining the support of production testing, ensuring physical integrity of the instrumentation being moved, and qualification of the...
February 5, 2015
ASTM E2500 – Risk-based testing has been in play for several years now. By design, there is a significant opportunity to avoid many lifecycle costs without creating an adverse impact to quality or...
August 29, 2013
Temperature Mapping is an intrinsic part of equipment validation. It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s...
April 5, 2013
No matter where I go I am always amazed at how many times the words calibration and verification are misused. I often hear statements like, “The instrument doesn’t need to be calibrated, the accuracy...
February 4, 2013
While Standard Operating Procedures (SOP’s) are widely and rightly used to control processes, there is sometimes a tendency within organizations to go “reference crazy”. In a well-meaning attempt to...