Quality assurance unit. A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facili- ties, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. The quality as- surance unit shall conduct inspections and maintain records appropriate to the study.
Quality assurance unit. A t es t i n g fa xxxx x x x x x ll h a ve a q u a li t y a ss ur a n ce un i t w h ic h s h a ll be r espo n s ible fo r m o n i t o r i n g e a c h s t u d y t o a ss ur e m a n a ge m e n t t h a t t h e fa cili- t ies, eq u ip m e n t , pe r so nn el, m e t h ods, p r a c t ices, r eco r ds, a n d co n t r ols a r e i n co nfo r m a n ce wi t h t h e r eg u l a t io n s i n t h i s p a r t . F o r a ny give n s t u d y , t h e q u a li t y a ss ur a n ce un i t s h a ll be e n t i r el y sep a r a t e f r o m a n d i n depe n de n t of t h e pe r so nn el e n g a ged i n t h e di r ec t io n a n d co n d u c t of t h a t s t u d y . T h e q u a li t y a s- s ur a n ce un i t s h a ll co n d u c t i n spec t io n s a n d m a i n t a i n r eco r ds a pp r op r i a t e t o t h e s t u d y .
Quality assurance unit an independent unit within the organization responsible for duties associated with assuring the quality of the API and its intermediates.
