Good Laboratory Practices (GLP) is a paramount laboratory guidance, which governs creditable and reproducible studies in laboratories across pharmaceutical, agrochemical and diagnostic industries. Hence, stepwise training of qualified personnel is essential to ensure the proper establishment, implementation and operation of a GLP laboratory. We have developed a graduate level course, to train students and professionals in creating a GLP environment for a medical device assay validation under WHO, FDA and EPA guidance. There are key emphases on designing all laboratory techniques under GLP, equipment IQ/OQ/PQ, creation of a Quality Assurance Unit, analysis of the assay design, production of assay data, and extensive writing of Standard Operating Procedures (SOP) to govern the laboratory. Students have demonstrated good laboratory safety skills, good documentation practices, comprehension of computer software validation, and implementation of electronic Quality Management System. Furthermore, the students are exposed to the regulatory process in FDA submission of laboratory data and product filing. This will allow them to operate and manage a GLP laboratory, incorporating future improvement such as Augmented Reality into GLP practices.

Building of a GLP laboratory through quality training in an academic course

256th National Meeting (2018)

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