Pharmaceutical process validation / edited by Robert A. Nash, Alfred H. Wachter.
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TextLanguage: English Series: Drugs and the pharmaceutical sciencesPublication details: New York : Marcel Dekker, c2003. Edition: International 3rd ed., rev. and expandedDescription: xxxvi, 860 p. : ill. ; 24 cmISBN: 0824708385 (alk. paper); 9780824708382Subject(s): Pharmaceutical industry -- Quality control | Drugs -- Standards -- United States | Drug Evaluation -- standards -- United States | Drug Industry -- standards -- United States | Quality ControlDDC classification: 615.1 LOC classification: RS189 | .P46 2003Online resources: Publisher description | WorldCat details | E-Book Fulltext | Item type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
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Dr. S. R. Lasker Library, EWU E-book | Non-fiction | 615.1 PHA 2003 (Browse shelf(Opens below)) | Not for loan | ||||
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Dr. S. R. Lasker Library, EWU Reserve Section | Non-fiction | 615.1 PHA 2003 (Browse shelf(Opens below)) | C-1 | Not For Loan | 16427 | ||
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Dr. S. R. Lasker Library, EWU Reserve Section | Non-fiction | 615.1 PHA 2003 (Browse shelf(Opens below)) | C-2 | Not For Loan | 16428 |
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| 615.1 PHA 2002 Pharmaceutics : | 615.1 PHA 2003 Pharmacology / | 615.1 PHA 2003 Pharmaceutical process validation / | 615.1 PHA 2003 Pharmaceutical process validation / | 615.1 PRI 2005 Principles of pharmacology : | 615.1 PRI 2017 Principles of pharmacology : | 615.1 RAP 2012 Rang and Dale's pharmacology / |
Includes bibliographical references and index.
TOC 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 phamaceutical 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 proess validation --
Harmonization GMPs, and validation.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends
Pharmacy
Sagar Shahanawaz
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