Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
Our discussion continues with the physical application of GMP design practices as influenced by the CDC and NIH regulations. The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained.
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.
This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.
A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.
This article presents a totality of evidence approach to show superior sterility performance of a well-designed closed system compared to conventional aseptic processing, and to design the control strategy.
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. This four-part article provides a foundational introduction to some of those aspects.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.