TY  - BOOK
AU  - Berry,Ira R.
AU  - Nash,Robert A.
TI  - Pharmaceutical process validation
T2  - Drugs and the pharmaceutical sciences
SN  - 9780824787776 (alk. paper)
U1  - 615.10685 BER 
PY  - 1993///
CY  - New York
PB  - Marcel Dekker
KW  - Pharmaceutical industry
KW  - Quality control
KW  - Drugs
KW  - Standards
KW  - United States
KW  - Drug Evaluation
KW  - standards
KW  - Drug Industry
KW  - Quality Control
KW  - Science: general issues
KW  - thema
KW  - Pharmacology
KW  - Pharmaceutical chemistry & technology
N1  - 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
ER  -