Risk-based assessment applied to QA GLP audits. How to fulfill regulatory requirements while making the best use of our common sense, knowledge, talents, and resources?

For ages the standard plan of internal good laboratory practice (GLP) audits has been designed according to the study critical phases concept. A decade ago the concept of facility-based and process-based audits was adopted, mostly under the influence of short-term and in vitro study design. For unclear reasons, the quarterly inspection scheme has been the prevailing rule. Nowadays, the emerging concept of risk management reaches the field of GLP. In this context, the following items are discussed: i) nature of risks associated with the GLP principles and GLP studies; ii) risk in a GLP environment and criteria used to characterize a risk in laboratory and in an environment of research and development; iii) quality and integrity of data, study results and scientific conclusions; iv) risks associated to the processes and those associated to the products; v) workers safety; vi) consumers safety; vii) variety of tools available for the assessment of the above specific risks; viii) principles of risk assessment (the five-step approach); ix) standard and specific risk assessment tools; x) required level of accuracy; xi) use of risk assessment results for the elaboration of audit plans; xi) nature of information obtained; xii) prioritization; xiii) intrinsic risk versus available resources; xiv) potential caveats from a regulatory standpoint; xv) compatibility of risk approach with the GLP regulatory requirements; xvi) how to demonstrate the GLP goals are fulfilled although some of the GLP specific requirements may not be; xvii) benefits of this approach for the audits efficiency and the quality systems improvement; xviii) what the risk approach provides to the organization; xix) how does risk approach efficiency compare to standard efficacy; xx) use of metrics for continuous improvement.