GLP

• promotes quality and validity of test data, hence reduces the cost of safety testing • ensures a consistently high standard of safety testing • ultimately improves human safety

• ensure personnel clearly understands functions they perform • provide training for these functions

• planning • carry out the study • documentation • evaluation • reporting • archiving

• competence, education, experience • CV, training records, job description • Defined responsibility • quality responsibility of their own work • working according to study plan and SOPs

• audit study plans • audit studies, facilites and processes • audit raw data and study reports • report to SD, PI and management • issue statement

• source of information • reference document • training aid • instruction guide

intended change to the study plan after the study initiation date

Unintended departure from the study plan after the study initiation date

• promt and accurate • clear and legible • signed and dated • permanent • changed or corrected properly

• to make information traceable • to be able to reconstruct work • to be able to verify the results

GLP is concerned with the organisational process and conditions under which non-clinical studies are • planned • performed • monitored • recorded • reported • archived