摘要：The development of good laboratory practice (GLP) consultancy and training from the
early 1980’s as well as the present industrial needs in GLP consultancy and training are reviewed. At
the very beginning, because the GLP principles were completely new, GLP experts often combined
basic training and consultancy in one package. Training was concerned with helping trainees to understand
the text of GLP regulations and make them aware of their responsibilities in the successful
management and conduct of GLP studies. With the development of the OECD GLP advisory and
consensus documents, training and consultancy became much more complete. Consultancy over the
next ten years will also be focusing on the harmonisation of regulatory references used on the same
site, such as good manufacturing practice (GMP), good clinical practice (GCP) and ISO norms,
and also on the incorporation of other quality concepts into the GLP laboratory (e.g., risk analysis,
quality indicators, continuous improvement). A significant increase in specialised consultancy is
expected as a shift towards in-vitro models becomes necessary through the quest for a new Research
and Development (R&D) paradigm. There will be two other important developments in training,
namely, the thrust for training programmes which can serve as certification and the need to provide
individualised training at distance, e.g., through Internet-based training programmes. Internet training,
followed by assessment modules, and covered by certification from an academic institution, is
expected to be run-of-the-mill in the year 2020.
关键词：good laboratory practice, good manufacturing practice, good clinical practice, ISO norms, consultancy,
training.
