| Edition |
2nd ed., rev. & expanded. |
| Description |
xli, 602 p. : ill. ; 24 cm. |
| Series |
Drugs and the pharmaceutical sciences ; 57 |
|
Drugs and the pharmaceutical sciences ; v. 57
|
| Bibliography |
Includes bibliographical references and index. |
| Contents |
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. 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 |
| Subject |
Pharmaceutical industry -- Quality control
|
|
Drugs -- Standards -- United States
|
|
Drug Evaluation -- standards -- United States
|
|
Drug Industry -- standards -- United States
|
|
Quality Control
|
| Added Author |
Berry, Ira R., 1942-
|
|
Nash, Robert A., 1930-
|
| ISBN |
0824787773 (alk. paper) |
|
