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Pharmaceutical process validation

Author: Ira R Berry; Robert A Nash
Publisher: New York : Marcel Dekker, ©2003.
Series: Drugs and the pharmaceutical sciences, v. 129.
Edition/Format:   Print book : English : International 3rd ed., rev. and expandedView all editions and formats
Summary:
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
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Document Type: Book
All Authors / Contributors: Ira R Berry; Robert A Nash
ISBN: 0824708385 9780824708382
OCLC Number: 54001293
Description: xxxvi, 860 pages : illustrations ; 24 cm.
Contents: Regulatory basis for process validation --
Prospective process validation --
Retrospective validation --
Sterilization validation --
Validation of solid dosage forms --
Validation for medical devices --
Validation of biotechnology processes --
Transdermal process validation --
Validation of lyophilization --
Validation of inhalation aerosols --
Process validation of phamaceutical ingredients --
Qualification of water and air handling systems --
Equipment and facility qualification --
Validation and verification of cleaning processes --
Validation of analytical methods and processes --
Computer system validation: controlling the manufacturing process --
Integrated packaging validation --
Analysis of retrospective production data using quality control charts --
Statistical methods for uniformity and dissolution testing --
Change control and SUPAC --
Process validation and quality assurance --
Validation in contract manufacturing --
Terminology of nonaseptic proess validation --
Harmonization GMPs, and validation.
Series Title: Drugs and the pharmaceutical sciences, v. 129.
Responsibility: edited by Robert A. Nash, Alfred H. Wachter.
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Abstract:

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

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