Pharmaceutical process validation /
edited by Ira R. Berry, Robert A. Nash.
- 2nd ed., rev. & expanded.
- New York : Marcel Dekker, c1993.
- xli, 602 p. : ill. ; 24 cm.
- Drugs and the pharmaceutical sciences ; 57 .
- Drugs and the pharmaceutical sciences ; v. 57 .
Includes bibliographical references and index.
(cont) Analysis of retrospective production data using quality control charts / Peter H. Cheng and John E. Dutt -- Multivariate graphical analysis in the validation of pharmaceutical products / Stephen T. Horhota -- Recent trends in process validation / John Y. Lee -- Validation terminology / Kenneth G. Chapman. Regulatory basis for process validation / Bernard T. Loftus -- Organizing for validation / J. Patrick Jeater, Leo F. Cullen and G.J. Papariello -- Validation of sterile products / Michael J. Akers and Neil R. Anderson -- Sterile products validation / Karl L. Hofmann, Jr. -- Validation of solid dosage forms / Jeffrey S. Rudolph -- Process validation and quality assurance / Carl B. Rifino -- Prospective process validation / Allen Y. Chao ... [et al.] -- Retrospective process validation / Chester J. Trubinski -- Validation of water systems for sterile and nonsterile products / Ward M. Johnson -- Cleaning validation / Paul Y. McCormick and Leo F. Cullen -- Equipment validation / Bohdan M. Ferenc, Luanne Kot and Rodney Thomas -- Process validation of raw materials / Ira R. Berry -- Analytical methods validation / Louis A. Pasteelnick -- Computer systems validation / James E. Krueger and Jonathan Krueger -- Validation of lyophilized products / Edward H. Trappler -- Validation of inhalation aerosols / Scott Bozzone.
Pharmaceutical industry--Quality control Drugs--Standards--United States Drug Evaluation--standards--United States Drug Industry--standards--United States Quality Control. Science: general issues Pharmacology Pharmaceutical chemistry & technology