Pharmaceutical process validation

著者

書誌事項

Pharmaceutical process validation

edited by Ira R. Berry, Robert A. Nash

（Drugs and the pharmaceutical sciences, v. 57）

M. Dekker, Inc., c1993

2nd ed., rev. & expanded

大学図書館所蔵 件 / 全6件

この図書・雑誌をさがす

注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

  • The regulatory basis for process validation, Bernard T. Loftus
  • organizing for validation, J. Patrick Jeater et al
  • sterilization validation of sterile products - fundamentals, Michael J. Akers and Neil R. Anderson
  • validation of sterile products - recent developments, Karl Hoffman
  • 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, Ward Johnson
  • cleaning validation, P.Y. McCormick and Leo F. Cullen
  • equipment validation, Jacek Bak et al
  • process validation of raw materials, Ira R. Berry
  • analytical methods validation, Louis A. Pasteelnick
  • computer systems validation, James E. 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
  • analysis of multivariant data, Stephen T. Horhota and Carolyn L. Aitken
  • current concepts in process validation, John Y. Lee
  • validation termilogy, Kenneth G. Chapman.

「Nielsen BookData」 より

関連文献： 1件中  1-1を表示

詳細情報

ページトップへ