Validation of Pharmaceutical Processes: Sterile Products

Contributor(s):

Material type: Text

TextPublication details: New York Marcel Dekker, Inc. 1999Edition: 2nd edDescription: 840pISBN:

9780824793845

Subject(s):

Pharmaceutical

DDC classification:

615.152 VAL

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Holdings
Item type	Current library	Item location	Collection	Call number	Status	Date due	Barcode	Item holds
Reference Book	NIMA Knowledge Centre	6th Floor Silence Zone	Reference	615.152 VAL (Browse shelf(Opens below))	Not For Loan		P0002412
Book	NIMA Knowledge Centre	9th Floor Reading Zone	General	615.152 VAL (Browse shelf(Opens below))	Available		P00777

Total holds: 0

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program and suggested the solutions

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