Quality Assurance Programme
Quality Assurance Programmes are there to independently assure studies performed are in compliance with the Principles of Good Laboratory Practice. In Module 02 we saw that Quality Assurance personnel should be:
- Familiar with test procedures
- Directly responsible to management
- Not involved in the conduct of the study
Quality Assurance personnel also have responsibilities during the study. What do you think they need to access? Click here to find out
- A copy of the approved study plan
- Relevant Standard Operating Procedures
- An up-to-date copy of the master schedule
In addition, Quality Assurance inspections need to determine that:
- Studies are conducted in accordance with the Principles of Good Laboratory Practice
- That study plans and SOPs have been made available to study personnel and are being followed
