Approach
Good Laboratory Practice (GLP) is the accepted standard promoted by the Office for Economic Co-operation and Development (OECD) for the generation of high quality and reliable test data related to the safety of industrial chemical substances within a framework of global harmonization. The FDA, and other pharmaceutical regulators, also supports GLP practices and procedures since products used in Phase I/ II clinical studies are produced under its guidelines. As drugs enter into larger scale Phase III studies cGMP regulations apply and so much of the experience from laboratory activities must be transferred. At SOLABS we provide a seamless interface between GLP and cGMP. Although best practice processes in each domain are often driven by the batch size, SOLABS is able to capture both the uniqueness of the laboratory environment through SOLABS GLP and the transferal of information during scale-up into SOLABS GMP.