CurrentStatusSummaryfortheDeficiencyduringGermanEGMPAuditok.docVIP

PAGE  PAGE 5 of 5 Current Status Summary for the Deficiencies during German EGMP Audit Deficiency No.DeficiencyCurrent statusClosed DateProposed Closed dateResponsible/TitleDeficiency 6.1-1Deficiencies found at the entrance and the passage for male operator to class B area on the first floor in workshop III.- No instruction of gowning procedure, for example, the prescription what place cloth put on and what operation taken on the room.ClosedJan 1,2009N/AN/A- No hand-dryer is in usage after washing handsClosedJan 1,2009N/AN/A- 1cm distance between the mirror and wall (the wall behind mirror is un-cleanable)ClosedNov 5,2008N/AN/A- The gowning procedure for class B is not applicable (wear clothes standing on the bench with hands of no gloves taken on)ClosedFeb 18,2009N/AN/A- No sterile packaging is used for clothes of class B areaClosedFeb 18,2009N/AN/ADeficiency 6.1-2Deficiencies found for entrance to class C for male operators on the 3rd floor in workshop I:- No interlocking system or a visual and/or audible warning system Not closedN/AApril 30, 2009Yang Zhiyun Director of workshop I- Lampshade is not cleanClosedDec 1,2008N/AN/A- Repeat usage of hand disinfection basinClosedJan 1,2009N/AN/A- No hand-dryer is usedClosedJan 1,2009N/AN/A- No prescription for gowning procedure on siteClosedJan 1,2009N/AN/ADeficiency No.DeficiencyCurrent statusClosed DateProposed Closed dateResponsible/TitleDeficiency 6.1-3Deficiencies found in the weighing room for raw materials of class C filtration area on the 3rd floor in workshop I:- Exhaust grid is not cleanClosedDec 1,2008N/AN/A- Air is exhausted to the un-classified areaClosedDec 1,2008N/AN/A- Weigh close to the exhaust gridClosedDec 1,2008N/AN/A- No monitoring device for air exchanging or pressureClosedJan 1,2009N/AN/A- Less air exchanging frequency and low pressure during auditClosedNov 4,2008N/