If you are interested in data integrity, you likely have read many articles about the topic. This blog delivers 7 new insights to data integrity, looking at it from different angles. Seven ways to...
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...
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...
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...
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...
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...
Today we’re back with the next step in the Nine Gate Transfer Process for Moving Production from site to site. So far we’ve covered the first four gates, which you can review in our last blog post....
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...
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...
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...