RT Journal Article
SR Electronic
T1 Inspection Qualification (IQ) and Operational Qualification (OQ) for a Vacuum Freeze-Dryer—Part I General Discussion
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 180
OP 188
VO 50
IS 3
A1 Jennings, T. A.
A1 Scheer, A.
A1 Emodi, A.
A1 Puderbach, L.
A1 King, S.
A1 Norton, T.
YR 1996
UL http://journal.pda.org/content/50/3/180.abstract
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.