Lab training: GLP/GCLP/GMP tips

Training in regulated labs starts with the person at the bench, not the slide deck. A Bioanalysis Zone column published on October 15, 2025 says hands-on shadowing and detailed procedural coaching are central to teaching Good Laboratory Practice, Good Clinical Laboratory Practice and Good Manufacturing Practice work. (bioanalysis-zone.com) The column was written by Catherine Vrentas, a former Thermo Fisher Scientific principal scientist who managed about 20 scientists and led development and validation of more than 100 assays. Bioanalysis Zone says she has mentored more than 60 scientists, students and interns over her career. (bioanalysis-zone.com) Vrentas argues that training has to cover routine physical steps such as pipetting and sample mixing because small technique differences can change assay performance and data quality. She says new hires and mid-career staff both need focused instruction on local documentation rules and standard operating procedures. (bioanalysis-zone.com) Good Laboratory Practice is the rule set for nonclinical studies used to support Food and Drug Administration research or marketing applications, and the agency says it is meant to assure data quality and integrity. The Food and Drug Administration’s training material says those rules also make studies easier to reconstruct during review and inspection. (fda.gov) University of Florida guidance summarizing Good Laboratory Practice says staff on a regulated study must have appropriate education, training and experience, and labs must maintain resumes, job descriptions and training records. The same guidance says personnel should review and follow the protocol or standard operating procedure for the study. (research.ufl.edu) Good Clinical Laboratory Practice applies those controls to clinical-trial sample testing. World Health Organization guidance says the framework was adopted to help laboratories produce safety and efficacy data that is repeatable, reliable, auditable and easy to reconstruct. (who.int) A separate National Institute of Allergy and Infectious Diseases guideline says managerial and technical staff in clinical-research testing must have education, training and experience that match their assigned duties. The guideline also points to policies and practices around training documentation, standard operating procedures and internal auditing. (niaid.nih.gov) Good Manufacturing Practice carries the same training burden into drug production. The Electronic Code of Federal Regulations says each person involved in manufacturing, processing, packing or holding a drug product must have the education, training and experience needed for assigned functions, and training must cover both the specific operation and current good manufacturing practice requirements. (ecfr.gov) That is why the column’s focus on shadowing, bench instruction and documented knowledge transfer fits the rulebooks as much as the workflow. In busy labs, the records that show who taught what, when, and to whom can matter as much as the assay result itself. (bioanalysis-zone.com; research.ufl.edu; ecfr.gov)