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Inspection qualification (IQ) and operational qualification (OQ) for a vacuum freeze-dryer--Part I. General
Abstract:
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.