The FDA issued a guidance document “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” (September 2025) (here) that focusses on the analytical approaches to be employed for comparative testing to demonstrate similarity between the proposed recombinant protein product and the reference (recognizing that the tools within the guidance could be applied […]
The USP has issued USP <1037> Process Analytical Technology – Theory and Practice, which is open for comments until the end of July 2025. This draft chapter is comprehensive and discusses the relationship between QbD and PAT, the fundamental requirements of PAT, PAT applications, and chemometrics, along with lifecycle management of PAT methods. The chapter espouses […]
On April 11, 2025, the ICH endorsed a draft guidance titled “Stability Testing of Drug Substances and Drug Products Q1” (here). This is a large, comprehensive guidance that applies to stability testing of chemically synthesized drug substances, biologics, vaccines, gene therapies, and combination products. The guidance addresses primary stability studies, commitment, ongoing and stability studies […]
Firms will commonly espouse the virtues of a robust company culture as it relates to Quality. I’ve frequently heard the chant that “culture trumps strategy” when addressing the need to drive quality improvement plans. There’s a lot of credence with such a statement as culture is addressing (at a high level) a collective belief with […]
A few months ago in this blog, we discussed the suitability of analytical methods and how a firm needs to demonstrate that a method is fit for purpose and, with that determination, there needs to be an understanding of the measurement uncertainty (MU) associated with the reported results (from that method). This blog can be […]
When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]
The WHO has a draft July 2013 guidance document titled “Deviation Handling and Quality Risk Management” that addresses the concept that not all Quality Events are equivalent and provides consideration for the classification of events. For example, an incident would be an event that does not: “…affect a product attribute, manufacturing operational parameter or the […]
Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]
I think we would all agree that the above saying very much applies to addressing any issues with the health of any firm’s Quality Management System. It is far less painful when your own Quality Oversight (QO) system self-identifies events rather than having them pointed out by a regulator during a health agency inspection, which […]
A review of recent Form 483s and Warning Letters shows that investigations continue to be a focus of FDA inspections, where the following citation is commonly issued: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether […]
