Jennings T A, Scheer A, Emodi A, Puderbach L, King S, Norton T
PDA J Pharm Sci Technol. 1996 May-Jun;50(3):180-8.
The principle objectives of this paper are (a), to develop the rationale for conducting an inspection qualification (IQ) and operational qualification (OQ) of a vacuum freeze-dryer; (b), to identify the key elements that require verification for completion of the IQ; and (c), to establish the necessary environmental and operational parameters necessary for the OQ of the vacuum freeze-dryer.
（a）阐述对真空冷冻干燥机进行安装确认（IQ）和运行确认（OQ）的基本原理；（b）确定完成IQ所需验证的关键要素；（c）确立真空冷冻干燥机OQ所需的必要环境和运行参数。
