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Pharmaceutical process validation /

Contributor(s): Berry, Ira R, 1942- | Nash, Robert A, 1930-.
Series: Drugs and the pharmaceutical sciences: v. 57.Publisher: New York : Marcel Dekker, c1993Edition: 2nd ed., rev. & expanded.Description: xli, 602 p. : ill. ; 24 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 0824787773 (alk. paper); 9780824787776.Subject(s): Pharmaceutical industry -- Quality control | Drugs -- Standards -- United States | Drug Evaluation -- standards -- United States | Drug Industry -- standards -- United States | Quality ControlDDC classification: 615.19
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.
(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.
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Holdings
Item type Current library Call number Copy number Status Date due Barcode Item holds
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 (Browse shelf(Opens below)) 1 Available 0035831
Total holds: 0

Includes bibliographical references and index.

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.

(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.

Edited by : James Swarbrick.

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