Test Facility Management
Click here for the OECD definition of test facility management
Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to the Principles of Good Laboratory Practice.
In Module 02 we learned about some of the responsibilities of test facility management in organising test facility infrastructure including the provision of sufficient number of qualified personnel, appropriate facilities, equipment and materials, establishment of Standard Operating Procedures, Quality Assurance Programme and archives.
There are also responsibilities regarding individual studies, click here to reveal them
Test facility management must provide suitable resources for the timely and proper conduct of the study. Thus test facility management responsibilities include the following:
- To ensure that for each study an individual with the appropriate qualifications, training and experience is designated by the management as the Study Director before the study is initiated. Also, if a Study Director needs to be replaced for any reason - this should be done according to established procedures
- To ensure documented approval of the study plan by the Study Director
- To ensure that the Study Director has made the approved study plan available to quality assurance personnel (so the quality assurance inspections can be planned)
Further information on study planning is given in Module 05 of this course.
