Do you know if your QC laboratory weighing practices are defensible? They may not be if weighing controls are treated as routine rather than as a critical part of the analytical process. Because weighing underpins many test procedures and methods, unreliable balance data can compromise results throughout an assay. Earlier this year (February 2026), the […]
Analytical method validation performed in industry is undergoing a significant transformation—and if your analytical method validation protocol templates haven’t evolved, now is the time to take a closer look. The United States Pharmacopeia (USP) has proposed a revision to USP <1225>, Validation of Analytical Procedures. This update brings the chapter into closer alignment with ICH Q2(R2) […]
There is no shortage of guidance on what a compliant visual inspection program should include. PDA guidance, USP chapters, FDA guidance, Annex 1, and other industry publications provide both high-level expectations and, in some cases, practical direction on key elements. Yet, when organizations are tasked with building or expanding a visual inspection program (particularly for new […]
A firm can face a situation in which it needs to engage a third party, and this may be encouraged or required in order to address a health-agency regulatory citation. For example, consider the following language from an FDA Warning Letter (WL): “Based upon the nature of the violations we identified at your firm, you […]
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On April 11, 2025, the ICH endorsed a draft guidance titled “Stability Testing of Drug Substances and Drug Products Q1” (here).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 […]
