MTU Cork Library Catalogue

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Pharmaceutical process validation / edited by Robert A. Nash and Alfred H. Wachter.

Contributor(s): Nash, Robert A, 1930- [editor] | Wachter, Alfred H [editor].
Material type: materialTypeLabelBookSeries: Drugs and the pharmaceutical sciences: v. 129.Publisher: New York : Informa Healthcare, [2007]Copyright date: ©2007Edition: International third edition, revised and expanded.Description: xxxvi, 860 pages : illustrations ; 24 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9780824708382 (hardback); 0824708385 (hardback).Subject(s): Pharmaceutical industry -- Quality control | Drugs -- Standards -- United States | Pharmaceutical industry -- United States | Quality controlAdditional physical formats: Electronic version: Pharmaceutical process validationDDC classification: 615.10685 Also available in electronic form.
Contents:
Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols - Process validation of pharmaceutical ingredients -- Qualification of water and air-handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic process validation -- Harmonization, GMPs, and validation
Holdings
Item type Current library Call number Status Notes Date due Barcode Item holds
3 day loan MTU Bishopstown Library Short Loan 615.10685 (Browse shelf(Opens below)) Available CIT Module CHEP 8026 - Core reading. 00218456
Total holds: 0

Enhanced descriptions from Syndetics:

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Includes bibliographical references and index.

Regulatory basis for process validation -- Prospective process validation -- Retrospective validation -- Sterilization validation -- Validation of solid dosage forms -- Validation for medical devices -- Validation of biotechnology processes -- Transdermal process validation -- Validation of lyophilization -- Validation of inhalation aerosols - Process validation of pharmaceutical ingredients -- Qualification of water and air-handling systems -- Equipment and facility qualification -- Validation and verification of cleaning processes -- Validation of analytical methods and processes -- Computer system validation: controlling the manufacturing process -- Integrated packaging validation -- Analysis of retrospective production data using quality control charts -- Statistical methods for uniformity and dissolution testing -- Change control and SUPAC -- Process validation and quality assurance -- Validation in contract manufacturing -- Terminology of nonaseptic process validation -- Harmonization, GMPs, and validation

CIT Module CHEP 8026 - Core reading.

Also available in electronic form.

Table of contents provided by Syndetics

  • Regulatory basis for process validation
  • prospective process validation
  • retrospective process validation
  • sterilization validation
  • validation of solid dosage forms
  • validation of medical devices
  • validation of biotechnology processes
  • transdermal process

Author notes provided by Syndetics

Robert A. Nash, Alfred H. Wachter

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