PT  - JOURNAL ARTICLE
AU  - Jennings, T. A.
AU  - Scheer, A.
AU  - Emodi, A.
AU  - Puderbach, L.
AU  - King, S.
AU  - Norton, T.
TI  - Inspection Qualification (IQ) and Operational Qualification (OQ) for a Vacuum Freeze-Dryer—Part I General Discussion
DP  - 1996 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 180--188
VI  - 50
IP  - 3
4099  - http://journal.pda.org/content/50/3/180.short
4100  - http://journal.pda.org/content/50/3/180.full
SO  - PDA J Pharm Sci Technol1996 May 01; 50
AB  - 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.