Pharmaceutical process validation / edited by Robert A. Nash, Alfred H. Wachter. - International 3rd ed., rev. and expanded. - New York : Marcel Dekker, c2003. - xxxvi, 860 p. : ill. ; 24 cm. - Drugs and the pharmaceutical sciences ; 129 . - Drugs and the pharmaceutical sciences ; .

Includes bibliographical references and index.

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. Table of contents

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

0824708385 (alk. paper) 9780824708382


Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Drug Evaluation--standards--United States.
Drug Industry--standards--United States.
Quality Control.

RS189 / .P46 2003

615.1 / PHA 2003

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