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Laboratory Animal Science > GLP > Flashcards

Flashcards in GLP Deck (11):

What is the purpose of 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


Management's responsibilites in GLP

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


Study director's responsibilities in GLP

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


Staff's responsibility

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


QA's responsibility

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


What is an SOP?

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


What are study plan amendments=

intended change to the study plan after the study initiation date


What are study plan deviations?

Unintended departure from the study plan after the study initiation date


Properties of records that adhere to GLP

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


What is the purpose of GLP documentation/recording?

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


What is GLP?

GLP is concerned with the organisational process and conditions under which non-clinical studies are

  • planned
  • performed
  • monitored
  • recorded
  • reported
  • archived