GLP

Question 1

What is the purpose of GLP

Answer 1

• 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

Question 2

Management’s responsibilites in GLP

Answer 2

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

Question 3

Study director’s responsibilities in GLP

Answer 3

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

Question 4

Staff’s responsibility

Answer 4

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

Question 5

QA’s responsibility

Answer 5

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

Question 6

What is an SOP?

Answer 6

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

Question 7

What are study plan amendments=

Answer 7

intended change to the study plan after the study initiation date

Question 8

What are study plan deviations?

Answer 8

Unintended departure from the study plan after the study initiation date

Question 9

Properties of records that adhere to GLP

Answer 9

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

Question 10

What is the purpose of GLP documentation/recording?

Answer 10

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

Question 11

What is GLP?

Answer 11

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

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