Q. Please tell us about yourself. What brought you to your current position?
I left college in the mid to late 90s in the UK and worked in the fine chemical/fuel additives industry as a development chemist at the plant and laboratory. Then I moved to the US, where I worked in the contract development and manufacturing organization (CDMO/CMO) for API and sterile finished product manufacturers. Here, I was overseeing laboratories from both a developmental and QC setting.
Eventually, I moved to a consultancy, and, currently, I apply the skills/learnings acquired over the years to assist companies with solving their proactive and reactive problems and challenges.
Q. What is your favorite part of the work you’ve done in this field?
Working with companies to develop functional and reliable analytical test procedures. I have worked with many great chemists who can solve complex problems from an analytical perspective; we collaborate to understand the risks associated with test methods (as no test procedure is risk-free). And this is what I care deeply about: Risk is not necessarily a bad thing, but not being aware of it is.
Q. What is your talk about?
Broadly, my talk discusses Analytical Quality by Design (AQbD), focusing on assessing whether a method suits a purpose. The talk deals with defining the error of measurement for a reported result, recognizing that all methods that generate a quantitative result have a certain level of error associated, and assessing if the level of error is acceptable/justifiable.
Q. Why do you think it’s important to discuss this topic with our audience?
Laboratories should understand the capability of the methods they use to generate data and, thereby, the level of error. Whenever a laboratory generates a certificate of analysis (COA) it is pivotal to consider the error of measurement for the reported results, and thus, the inherent risk associated with a specification.
Paul Mason, PhD, is the executive director at Lachman Consultants. With over 25 years of experience in the pharmaceutical industry, Paul is a quality control (QC) chemist experienced in sterile parenteral, API, and solid oral dosage forms. His experience spans finished dosage forms, CMOs, and API (intermediates) manufacture support in both a QC and analytical development setting.
Register today for free to attend Paul’s and other insightful webinars at the 2025 Laboratory Quality and Compliance Week!
