Establishing a GLP compliance program for non‐toxicology safety studies

Good Laboratory Practices (GLP) were originally promulgated for regulating non-clinical laboratory safety studies, specifically, toxicology studies. Since the introduction of GLPs, regulatory agencies worldwide have increasingly required additional types of safety studies, such as viral clearance studies for plasma-derived and biotechnology products, to be performed in accordance with the principles of the GLP regulations. Establishment of a GLP compliance program for non-toxicology safety studies, however, has many challenges. In a viral validation study, a bench-scale model of a manufacturing step is developed and is used to evaluate virus clearance, and so, many GLP elements such as the definitions for test article and test system, are not directly applicable. In spite of these difficulties, GLP concepts can be implemented as much as possible to ensure the integrity of the study. A GLP compliance program, with application to a number of disciplines, including viral validation, was established at Bayer HealthCare Biological Products Division. Integral to the effort was a multi-functional team comprised of members from the quality Assurance Unit (QAU) and different departments within Research and Development (R&D). The team is primarily responsible for preparing, reviewing, and harmonizing the Standard Operating Procedures (SOPs) used in all regulated non-clinical laboratory studies. Through the effective interactions between R&D and QAU, study participants gain essential knowledge and experience in GLPs. In addition to performing audits, the QAU plays an important role in the implementation of strategies for GLP compliance. As a result, significant progress has been made toward meeting the challenges of establishing a GLP compliance program for non-toxicology safety studies. Copyright © 2004 John Wiley & Sons, Ltd.