Guidance for Industry | 合法醫療器材資訊網
2018年8月9日—PRODUCTIONANDIN-PROCESSCONTROLS(8)...representstheFoodandDrugAdministration's(FDA's)currentthinkingonthistopic.
[PDF version of this document[1]]
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) August 2001 ICH
Additional copies are available from:
Office of Training and Communications Division of Communications Management Drug Information Branch, HFD-210 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 (Internet) http://www.fda.gov/cder/guidance/index.htm[2]
or
Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 Internet: http://www.fda.gov/cber/guid...
CFR | 合法醫療器材資訊網
Control Strategy and ICH Q11 | 合法醫療器材資訊網
Guidance for Industry | 合法醫療器材資訊網
Process Validation | 合法醫療器材資訊網
Production and Process Controls (P&PC) | 合法醫療器材資訊網
Production and Process Controls | 合法醫療器材資訊網
Production and Process Controls | 合法醫療器材資訊網
Questions and Answers on Current Good Manufacturing ... | 合法醫療器材資訊網
【"蓓麗嘉" 液體藥物給藥器 (未滅菌)】許可證字號:衛部醫器輸壹字第017638號
器材品名:"蓓麗嘉"液體藥物給藥器(未滅菌)許可證字號:衛部醫器輸壹字第017638號註銷狀態:註銷日期:註銷理由:有效日期:2022/0...
【"好力齒"假牙清潔錠 (未滅菌)】許可證字號:衛部醫器輸壹字第020481號
器材品名:"好力齒"假牙清潔錠(未滅菌)許可證字號:衛部醫器輸壹字第020481號註銷狀態:註銷日期:註銷理由:有效日期:2024/05/24...
【"聯合" 特殊生化能力試驗組套 (未滅菌)】許可證字號:衛部醫器製壹字第005824號
器材品名:"聯合"特殊生化能力試驗組套(未滅菌)許可證字號:衛部醫器製壹字第005824號註銷狀態:註銷日期:註銷理由:有效日期:20...
【“崔普”搬運墊(未滅菌)】許可證字號:衛署醫器陸輸壹字第001259號
器材品名:“崔普”搬運墊(未滅菌)許可證字號:衛署醫器陸輸壹字第001259號註銷狀態:已註銷註銷日期:2018/08/21註銷理由:未展...