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Pharmaceutical manufacturing handbook : regulations and quality

Author: Shayne C Gad
Publisher: Hoboken, N.J. : Wiley-Interscience, ©2008.
Edition/Format:   Print book : EnglishView all editions and formats
Database:WorldCat
Summary:

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of  Read more...

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Genre/Form: Handbooks and manuals
Handbooks, manuals, etc
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Shayne C Gad
ISBN: 9780470259597 0470259590
OCLC Number: 191751598
Description: xiii, 841 pages : illustrations ; 26 cm
Contents: Section 1 Good manufacturing practices (GMP) and other FDA guidelines --
Good manufacturing practices (GMP) and other FDA guidelines / James R. Harris --
Enforcement of current good manufacturing practices / Kenneth L. Nolan --
Scale-up and postapproval changes (SUPAC) regulations / Puneet Sharma, Srinivas Ganta, Sanjay Garg --
GMP-compliant propagation of human multipotent mesenchymal stromal cells / Eve Rohde [and others] --
Section 2 International regulations of good manufacturing practices --
National GMP regulations and codes and international GMP guides and guidelines: correspondences and differences / Marko Narhi, Katrina Nordstrom --
Section 3 quality --
Analytical and computational methods and examples for designing and controlling total quality management pharmaceutical manufacturing systems / Paul G. Ranky [and others] --
Role of quality systems and audits in pharmaceutical manufacturing environments / Evan B. Siegel, James M. Barquest --
Creating and managing a quality management system / Edward R. Arling, Michelle E. Dowling, Paul A. Frankel --
Quality process improvement / Jyh-hone Wang. Section 4 process analytical technology (PAT) --
Case for process analytical technology: regulatory and industrial perspectives / Robert P. Cogdill --
Process analytical technology / Michel Ulmschneider, Yves Roggo --
Chemical imaging and Chemometrics: Useful tools for process analytical technology / Yves Roggo, Michel Ulmschneider --
Section 5 personnel --
Personnel training in pharmaceutical manufacturing / David A Gallup, Katherine V. Domenick, Marge Gillig --
Section 6 Contamination and contamination control --
Origin of contamination / Denise Bohrer --
Quantitation of markers for gram-negative and gram-positive endotoxins in work environment and as contaminants in pharmaceutical products using gas chromatography-tandem mass spectrometry / Alvin Fox --
Microbiology of nonsterile pharmaceutical manufacturing / Ranga Velagaleti --
Section 7 drug stabilty --
Stability and shelf life of pharmaceutical products / Ranga Velagaleti --
Drug stabilty / Nazario D. Ramirez-Beltran, Harry Rodriquez, L. Antonio Estevez --
Effects of packaging on stabilty of drugs and drug products / Emmanuel A Webster --
Alternative accelerated methods for studying drug stability: variable-parameter kinetics / Giuseppe Alibrandi --
Section 8 Validation --
Analytical method validation: principles and practices / Chung Chow Chan --
Analytical method validation and quality assurance / Isabel Taverniers, Erik Van Bockstaele, Marc De Loose --
Validation of laboratory instruments / Herman Lam --
Pharmaceutical manufacturing validation principles / E.B. Souto T. Vasconcelos D.C. Ferreira, B. Sarmento.
Responsibility: [edited by] Shayne Cox Gad.
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This book is a valuable reference ... .The book contains everything you need to ensure full compliance and superior quality control. ( Pharmaceutical Technology Magazine , July 2, 2008)

 
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