GLP Flashcards
1
Q
What is the purpose of GLP
A
- 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
Q
Management’s responsibilites in GLP
A
- ensure personnel clearly understands functions they perform
- provide training for these functions
3
Q
Study director’s responsibilities in GLP
A
- planning
- carry out the study
- documentation
- evaluation
- reporting
- archiving
4
Q
Staff’s responsibility
A
- competence, education, experience
- CV, training records, job description
- Defined responsibility
- quality responsibility of their own work
- working according to study plan and SOPs
5
Q
QA’s responsibility
A
- audit study plans
- audit studies, facilites and processes
- audit raw data and study reports
- report to SD, PI and management
- issue statement
6
Q
What is an SOP?
A
- source of information
- reference document
- training aid
- instruction guide
7
Q
What are study plan amendments=
A
intended change to the study plan after the study initiation date
8
Q
What are study plan deviations?
A
Unintended departure from the study plan after the study initiation date
9
Q
Properties of records that adhere to GLP
A
- promt and accurate
- clear and legible
- signed and dated
- permanent
- changed or corrected properly
10
Q
What is the purpose of GLP documentation/recording?
A
- to make information traceable
- to be able to reconstruct work
- to be able to verify the results
11
Q
What is GLP?
A
GLP is concerned with the organisational process and conditions under which non-clinical studies are
- planned
- performed
- monitored
- recorded
- reported
- archived
