Paragraph 4 General

The laboratory should have a documented quality assurance programme to ensure that studies performed are in compliance with the principles of good laboratory practice.

The quality assurance programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.

This individual or these individuals should not be involved in the conduct of safety study being assured.

This individual or these individuals should report any findings in writing directly to management and to the study director.