The Resource Handbook of pharmaceutical manufacturing formulations, Volume 6, Sterile products, Sarfaraz K. Niazi

Handbook of pharmaceutical manufacturing formulations, Volume 6, Sterile products, Sarfaraz K. Niazi

Label
Handbook of pharmaceutical manufacturing formulations, Volume 6, Sterile products
Title
Handbook of pharmaceutical manufacturing formulations
Title number
Volume 6
Title part
Sterile products
Statement of responsibility
Sarfaraz K. Niazi
Title variation
Sterile products
Creator
Subject
Genre
Language
eng
Summary
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry. Highlights from Sterile Products, Volume Six include:formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance
Cataloging source
N$T
Dewey number
615/.19
Illustrations
illustrations
Index
index present
LC call number
RS200
LC item number
.N53 2009eb vol. 6
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
  • handbooks
Label
Handbook of pharmaceutical manufacturing formulations, Volume 6, Sterile products, Sarfaraz K. Niazi
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Front Cover -- Volume 6; Preface to the Series-Second Edition; Preface to the Series-First Edition; About the Author; Part I -- Regulatory and Manufacturing; 1 -- Sterile Manufacturing Formulations Template; 2 -- GMP Audit Template, EU Guidelines; 3 -- Inspection of Sterile Product Manufacturing Facilities; 4 -New Drug Application for Sterilized Products; 5 -- Validation of Cleaning Process; 6 -- Viral Safety Evaluation of Biotechnology ProductsDerived from Cell Lines of Human or Animal Origin; 7 -- Analysis of the Expression Construct in Cells Usedfor Production of rDNA-Derived Protein Products
  • 8 -- Stability Testing of Biotechnological/Biological Products9 -- Derivation and Characterization of Cell Substrates Used forProduction of Biotechnological/Biological Products; 10 -- Comparability of Biotechnological/Biological ProductsSubject to Changes in Their Manufacturing Process; 11 -- Specifications: Test Procedures and Acceptance Criteriafor Biotechnological/Biological Products; 12 -- Essential Clean-Room Design Elements; 13 -- Approved Excipients in Sterile Dosage Forms; Part II -- Manufacturing Formulations; Index; Back Cover
Control code
ocn502428203
Dimensions
unknown
Edition
2nd ed
Extent
1 online resource (xxi, 434 pages)
File format
unknown
Form of item
online
Isbn
9781420081312
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
Quality assurance targets
not applicable
http://library.link/vocab/recordID
.b24475129
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)502428203
  • pebco1420081314

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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