GLP/GCLP/GMP training column

Good Laboratory Practice, Good Clinical Laboratory Practice, and Good Manufacturing Practice are rulebooks for how regulated labs generate data and products that other people can trust. In an October 15, 2025 Bioanalysis Zone column, Catherine Vrentas argued that training in those settings has to go beyond onboarding and become a repeatable system for teaching hands-on work. (bioanalysis-zone.com) Vrentas wrote that routine steps such as pipetting, mixing, and sample handling can change assay performance and data quality, even when the written procedure looks straightforward on paper. She said new and experienced bioanalysts both need detailed procedural training and shadowing, not just a one-time review of standard operating procedures. (bioanalysis-zone.com) In regulated labs, that emphasis lines up with the rules. The Food and Drug Administration says Good Laboratory Practice under 21 Code of Federal Regulations Part 58 is meant to assure the quality and integrity of safety data from nonclinical studies, and Good Clinical Laboratory Practice applies Good Laboratory Practice principles to clinical-trial sample testing while preserving Good Clinical Practice requirements. (fda.gov) (globalhealthtrainingcentre.tghn.org) The practical problem is that written instructions do not capture every physical motion. Vrentas pointed to shadowing as a way to transfer tacit knowledge — the small choices an experienced analyst makes at the bench — so supervisors can turn individual habits into reproducible lab methods. (bioanalysis-zone.com) That fits the compliance logic behind these systems. The European Medicines Agency says Good Laboratory Practice covers how nonclinical studies are planned, performed, monitored, recorded, reported, and archived, which means training has to support the full chain of work rather than a single task in isolation. (ema.europa.eu) Vrentas framed supervisors as the hinge point in that chain. Her column described training as an ongoing management responsibility that includes observing technique, checking understanding, and building competency in the people who will later train someone else. (bioanalysis-zone.com) The argument lands in labs that increasingly sit between research and regulated production. Good Manufacturing Practice governs manufacturing quality systems, while Good Laboratory Practice covers nonclinical safety studies and Good Clinical Laboratory Practice covers trial-sample testing, so handoffs between teams can become compliance risks if methods are not taught the same way every time. (biobostonconsulting.com) (fda.gov) (globalhealthtrainingcentre.tghn.org) Vrentas made the case that the best training investment is not another instrument but a system that captures bench knowledge before it walks out the door. In regulated labs, reproducibility starts with how one analyst shows the next analyst what “done correctly” looks like. (bioanalysis-zone.com)