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Inspection qualification (IQ) and operational qualification (OQ) for a vacuum freeze-dryer--Part II: Inspection
T A Jennings1, A Scheer, A Emodi
1Phase Technologies, Inc., Conshohocken, PA, USA.
PDA Journal of Pharmaceutical Science and Technology
|July 1, 1996
Abstract:
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.