GLP (Week 1)

Question 1

What is GLP?

Answer 1

Quality system concerned with the organisational process and the conditions under which non clinical health and environmental studies are planned, performed, monitored, recorded, archived, and reported

Determines hazards and risks to users and environment

Question 2

What does GLP ensure?

Answer 2

Safety testing of chemicals:
Is carried out correctly 
Results are reliable 
Prevent fraudulent data 
Ensure data submitted to regulatory authorities is a true reflection of test results

Question 3

What is GLP concerned with?

Answer 3

Data integrity in safety studies for submission to regulatory authorities
Ensures data from safety trials can be authenticated
Lab as a whole is assessed

Question 4

How is GLP regulated?

Answer 4

Regulated by GLP monitoring authority in UK
It’s an agency of the department of health
Any test facilities which conducts regulatory studies must be a member of the GLPMA
Test facility must be inspected and certified by the GLPMA

Question 5

How to carry out safety studies?

Answer 5

Labs apply to GLPMA to join programmes
GLPMA inspects facility, GLP quality system, suitability of premises and facilities
Will be inspected 12-30 months

Question 6

History of GLP

Answer 6

OECD principles were developed by an expert group of the organisation of economic cooperation and development
The principles were based on GLP regulations for non clinical studies published by the US food and rug administration (FDA) in 1976