Normal view MARC view ISBD view

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. TOC

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



ISBN: 0824708385 (alk. paper) 9780824708382

LCCN: 2003279593

Subjects--Topical Terms:
Pharmaceutical industry--Quality control.
Drugs--Standards--United States.
Drug Evaluation--standards--United States.
Drug Industry--standards--United States.
Quality Control.

LC Class. No.: RS189 / .P46 2003

Dewey Class. No.: 615.1 / PHA 2003