The principles of good laboratory practice: Application to in vitro toxicology studies - The report and recommendations of ECVAM Workshop 37

This is the report of the thirty-seventh of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAPM's main goal, as defined in 1993 by its Scientific Advisory Committee , is to promote the scientific and regulatory acceptance of alternative met hods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well-informed about the state-of-the-art of non-animal test development and validation, and the potential for the! possible incorporation of alternati ve tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at whi ch small groups of invited experts would review the current status of in vi tro tests and their potential uses and make recommendations about the best ways forward (1). In addition, other topics related to the Three Rs (reduct ion, refinement, replacement) concept of alternatives to animal experiments have been considered in several ECVAM workshops. ECVAM brought together experts in the field of cell culture technology and Good Laboratory Practice (GLP) to stimulate the use and acceptance of in vi tro toxicology data during the human risk assessment process, at both the E uropean and world levels. The ECVAM workshop on The Principles of Good Labo ratory Practice: Application to In Vitro Toxicology Studies was held in Ang era, Italy, on 6-9 December 1998. The workshop was chaired by Robin Cooper- Hannan (Qualitas, Hurstpierpoint, UK) and John Harbell (Institute for In Vi tro Science, Gaithersburg, MD, USA), and was attended by cell culture techn ologists, toxicologists and quality assurance personnel from industry, acad emia and government. The aim of the workshop was to discuss and make recomm endations on the application of the OECD Principles of GLP to good quality cell and tissue culture practices. In addition to reviewing the application of GLP to single-site and multi-site studies, this document pays specific attention to multi-study in vitro toxicology trials, including ECVAM's prev alidation/validation studies which employ blind-coded chemicals. The consen sus reached at the workshop was that validation efforts for in vitro toxico logy studies should be carried out under GLP, to facilitate the regulatory acceptance of high quality validated in vitro tests.