ยา Venterone Lot.650101 พบว่า Airbo

ยา Venterone Lot.650101 พบว่า Airbone ขนาด 5.0 Micron มีค่าเกิน Alert Limit ที่กำหนด มีการระบุว่าหัวบรรจุ 4 หัว break down เกิดจากเศษแก้วแตก แต่ไม่ได้ออก deviation ตามที่กำหนดใน SOP.QA.94 การควบคุมการเบี่ยงเบน (Control of Deviation) Rev.02 วันที่บังคับใช้ 24 ก.พ.57 ระบุว่า ข้อ 11 ผลการตรวจสอบติดตามสอบติดตามสภาวะแวดล้อม เช่น เชื้อและอนุภาคไม่ผ่าน Alert Limit จะต้องออก Deviation report

Results (English) 1:

Ya Venterone Lot.650101 5.0 Micron size contain Airbone found exceeded a defined Limit is specified, the Alert that contains 4 head break down caused by a broken glass, debris, but they did not issue the deviation as defined in SOP.QA.94 to control the deviation (Deviation of Control), the effective date, Feb. 24 57 Rev.02. Specifies that the query results, track 11 track environments, such as infection and particles can pass Alert Limit Deviation report.

Results (English) 2:

Drug Venterone Lot.650101 found Airbone 5.0 Micron size exceeds the Alert Limit has been identified as the fourth head packed break down caused by broken glass but did not leave deviation as defined in SOP.QA.94 control. Deviation (Control of Deviation) Rev.02 day mandatory 24-Feb-57 states that Article 11 of the tracking, monitoring environmental conditions, such as infection and particles do not pass will be issued Alert Limit Deviation report.

Results (English) 3:

Medicine Venterone Lot.650101 found Airbone size 5.0 Micron exceeded the limit. Alert Limit has identified head 4 packing head break down. Caused by broken glass, but not out deviation as defined in SOP.QA.94 control deviation (Control of Deviation) Rev.02 date required 24 Feb57 stated that the 11 monitoring tracking test track environmental conditions such as infection and particles through Alert Limit must be removed Deviation report.