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Laboratory Animal Science > GLP > Flashcards

Flashcards in GLP Deck (11):
1

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

2

Management's responsibilites in GLP

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

3

Study director's responsibilities in GLP

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

4

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

5

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

6

What is an SOP?

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

7

What are study plan amendments=

intended change to the study plan after the study initiation date

8

What are study plan deviations?

Unintended departure from the study plan after the study initiation date

9

Properties of records that adhere to GLP

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

10

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

11

What is GLP?

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

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