Challenges in the Toxicological(Mutagenic and Teratogenic)/Environmental methods under the GLP system

  • Andrson, D. (University of Bradford)
  • 발행 : 2002.10.01


GLP regulations were initially “promulgated to address assuring the validity of data in the wake of investigations by EPA and FDA during the mid -1970's which revealed that some studies submitted to the agencies had not been conducted in accordance with acceptable laboratory practices.” [1] In the early 1970s, results of an investigation by the FDA in about 40 laboratories revealed many cases of badly managed studies, poor training of personnel and some cases of deliberate fraud. The general findings were that there were poorly trained study directors and study personnel, poorly designed protocols, protocols not followed, procedures not conducted as described, raw data badly collected, data not correctly identified, data without traceability, data not verified and approved by responsible persons, lack of standardised procedures, poor animal husbandry, inadequate characterisation of test items and test systems, inadequate resources, equipment poorly calibrated or otherwise qualified, reports not sufficiently verified, not an accurate account of the actual study, not a proper reflection of raw data and inadequate archiving of data. These problems are not just past history, since they resurface time and time again, even in quite recent times as the experience of GLP inspectors shows [1]. The GLPs specify minimum practices and procedures in order to ensure the quality and integrity of data submitted in accordance with a regulatory requirement