gogo
Amazon cover image
Image from Amazon.com

Pharmaceutical process validation / edited by Ira R. Berry, Robert A. Nash.

Contributor(s): Material type: TextTextSeries: Drugs and the pharmaceutical sciences ; v. 57Publication details: New York : Marcel Dekker, c1993.Edition: 2nd ed., rev. & expandedDescription: xli, 602 p. : ill. ; 24 cmISBN:
  • 9780824787776 (alk. paper)
  • 0824787773
  • 9780429222979
Subject(s): DDC classification:
  • 615.10685 BER
Contents:
(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.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 615.10685 BER (Browse shelf(Opens below)) 1 Available 111664

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.

Powered by Koha