Pharmaceutical process validation
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation
Print Book, English, ©1993
2nd ed., rev. & expanded View all formats and editions
Marcel Dekker, New York, ©1993
Drugs and the pharmaceutical sciences, v. 57, 57
xli, 602 pages : illustrations ; 24 cm.
9780824787776, 0824787773
27037034
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 [and others]
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. (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