In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.
This article will first present the definitions and requirements regarding risk pertaining to the control of suppliers and then introduce some tools to incorporate and integrate risk management techniques within the QMS specifically applied to supplier management/purchasing controls.
In 2014, TransCelerate BioPharma launched an initiative dedicated to creating a common protocol template (CPT), with a vision of addressing the increasing complexity of clinical trial protocol development and supporting the pursuit of protocol quality through a practical, harmonized and adoptable approach. Several weeks ago, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) released a final version of its own common protocol template — noting that it was in alignment with TransCelerate’s CPT, specifically, the new enhanced technology-enabled edition. They, like TransCelerate, recognized that the clinical trial protocol deserved renewed attention and modernization.
In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized plastic equipment for both clinical batch and, where applicable, production scale manufacturing. Single-use process equipment can be used and then disposed of, eliminating the development time to validate the sterilization and in-facility sterilization downtime, as well as development time to qualify and verify the cleaning and commensurate cleaning downtime.
Prior to the passage of the Orphan Drug Act of 1983 (ODA), a meager 38 orphan drugs (ODs) were approved, corresponding to — at best — an approved drug for less than 1 percent of an estimated 7,000 orphan diseases.
Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood.
Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.
The real issue in developing a QMS failure mode effects analysis (qFMEA) for the quality management system is how to develop the scales traditionally used to calculate the risk priority number.
Inadequate communication between the consultant and the client, especially at the initial engagement phase, is often not taken seriously enough or addressed sufficiently on both sides.