Self-correcting organizations are companies in the GXP regulated industry that do not shy away from defects and defect discovery. As Joseph Zec explains in the following interview and recording, there are common, key characteristics of a self-correcting organization that, once adopted and implemented, will lead to global regulatory compliance. Self-Correcting Organizations: Q&A with Joseph...
In this Part, the scope of this risk management tool is outlined, and the structure of the tool is explained. Some of the key...Download
You have a customer with product ready to be lyophilized. The new lyophilizer has arrived and is ready to be installed at your...Download
CB.Hep-1 is a mouse monoclonal antibody (MAb) secreted by the hybridoma 48/1/5/4, specific for the “a” determinant of the...Download
Ultimately, we are ultimately responsible for assuring the quality and compliance of our products. Thus, by aligning...Download
The Winter and Spring Issues of the Journal of GXP Compliance featured papers on technical/quality agreements, devoloping test cases, academic GLP and GCLP programs, change control, and validating the SaaS application. The following questions are adapted from papers published in the Journal of GXP Compliance and are designed to test your knowledge of the best practices for...
Any business seeks reduced project timelines, reduced project costs, and improved production. This is the essence of lean manufacturing, and it is the subject of Sujeev Ruban’s presentation at IVT’s Validation Week Canada. Adapted from the presentation, “Incorporate Lean Techniques into Your C&Q Program,” the following are the three keys concepts that need to be implemented to have a...
An FDA inspector is coming to your facility right now. They may not come tomorrow, but every pharmaceutical, biologic, and medical device manufacturer will have to face and manage an FDA inspection. There are some vital pre-inspection activities, given by Bill Hall at IVT’s 18th Annual Validation Week, that will guarantee not only confidence when confronting an FDA inspection but also compliance.
As the FDA inspector scours the halls of your facility, panic begins to set in. Regardless of preparation, how your group handles an FDA inspection can be the difference between a regulatory citation and a big sigh of relief. The following are six things, taken from a presentation from Bill Hall at IVT’s 18th Annual Validation Week, you need to consider during an FDA inspection.
This paper presents an overview of the validation of microbiological methods, considering some of the limitations and outlining the key criteria that may be applicable for assessment. Such a review is additionally useful given the revision process in relation to the United States and European Pharmacopeia in relation to alternative methods, and associated regulatory interest.