RT Journal Article
SR Electronic
T1 Inspection Qualification (IQ) and Operational Qualification (OQ) for a Vacuum Freeze-Dryer—Part II: Inspection Qualification
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 205
OP 212
VO 50
IS 4
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/50/4/205.abstract
AB This paper demonstrates the importance of the inspection qualification (IQ). It was shown that the facilities were adequate to house the dryer and its associated instrumentation, and that the facilities had sufficient utilities to operate the dryer. The IQ established that the design and construction of the dryer was in agreement with the proposed hardware and design specifications. It was verified that the dryer was constructed in accordance with specifications set-forth by the equipment manufacturer.