Good laboratory practice 30 years on: challenges for industry.
The principles of good laboratory practice (GLP) have undergone little change since they were established 30 years ago. Conversely, there have been huge advances in science and technology during this time. Test facilities (TF) have been challenged to utilise these advancements and thus enhance the quality of their programmes of non-clinical safety testing. As a consequence, practices are very different today compared with the late 1970's. The scientific advancements have also extended the boundaries of GLP principles and TF must maintain an awareness of the scope of GLP. TF now typically operate on a global basis and strive for harmonised systems, processes and procedures. This is particularly challenging when national monitoring authorities (MA) have different expectations and interpretations of the GLP principles. Other industry challenges that have emerged in recent years include the management of multi-site studies and the independence of the quality assurance (QA) unit.
Goodwin
Mark
M
Preclinical Compliance, Glaxo SmithKline, Park Road, Ware, Hertfordshire SG12 0DP, UK. mark.b.goodwin@gsk.com
D019411:Clinical Laboratory Techniques / Q000592:standards*; D007221:Industry / Q000592:standards*; D011786:Quality Control; D012926:Social Control, Formal; D013997:Time Factors