Description |
1 online resource (xxi, 434 pages) : illustrations |
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 |
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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 |
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 |
Bibliography |
Includes bibliographical references and index |
Notes |
Print version record |
Subject |
Drugs -- Dosage forms -- Handbooks, manuals, etc
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Drugs -- Dosage forms.
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Pharmaceutical technology.
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Drug Compounding
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Dosage Forms
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Formularies as Topic
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Technology, Pharmaceutical
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Pharmaceutical technology
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Drugs -- Dosage forms
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Genre/Form |
handbooks.
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Handbooks and manuals
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Handbooks and manuals.
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Guides et manuels.
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Form |
Electronic book
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ISBN |
9781420081312 |
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1420081314 |
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