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Practical Pharmaceutical Engineering

Practical Pharmaceutical Engineering

Authors
Publisher Blackwell Science
Year 01/02/2019
Edition First
Pages 576
Version hardback
Readership level Professional and scholarly
Language English
ISBN 9780470410325
Categories Biotechnology, Chemical engineering, Pharmaceutical technology
$158.02 (with VAT)
580.99 PLN / €129.55 / £111.30
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Book description

This book provides professionals in the pharmaceutical industries a basic understanding of the key elements of pharmaceutical and biotech manufacturing and design. The emphasis is to prepare or reinforce skills required for personnel to knowledgeably deal with projects and programs often performed by consulting firms, engineering firms, and/or consultants. It provides important information on pharmaceutical operation issues required for meeting regulatory guidelines, plant support design, and project engineering specifics, as well as HVAC systems, water systems, electric systems, and quality assurance. Individuals employed by pharmaceutical, bio-tech, engineering firms, and consulting firms will need this resource.

Practical Pharmaceutical Engineering

Table of contents

Preface xiii


1 US Regulations for the Pharmaceutical Industries 1


1.1 Introduction 1


1.2 The FDA: Formation of a Regulatory Agency 2


1.3 FDA's Seven Program Centers and Their Responsibility 6


1.3.1 Center for Biologics Evaluation and Research 6


1.3.2 Center for Drug Evaluation and Research 6


1.3.3 Center for Devices and Radiological Health 6


1.3.4 Center for Food Safety and Applied Nutrition 6


1.3.5 Center for Veterinary Medicine 6


1.3.6 Office of Combinational Products 6


1.3.7 Office of Regulatory Affairs 7


1.4 New Drug Development 7


1.4.1 Discovery 7


1.4.2 Investigational New Drug Application 8


1.4.3 Preclinical Studies (Animal) 9


1.4.4 Clinical Studies 10


1.5 Commercializing the New Drug 16


1.5.1 New Drug Application 17


1.6 Harmonization 23


1.6.1 Common Technical Document 23


1.7 Review Process of US NDA 25


1.8 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 27


1.8.1 Organization and Personnel 27


1.8.2 Building and Facilities 28


1.8.3 Equipment 28


1.8.4 Control of Components and Drug Product Containers and Closures 29


1.8.5 Production and Process Controls 29


1.8.6 Packaging and Labeling Control 30


1.8.7 Holding and Distribution 31


1.8.8 Laboratory Controls 31


1.8.9 Records and Reports 32


1.8.10 Returned and Salvaged Drug Products 33


1.8.11 Other 33


1.9 Compliance 34


1.9.1 Quality System 35


1.9.2 Facilities and Equipment System 35


1.9.3 Materials System 36


1.9.4 Production System 36


1.9.5 Packaging and Labeling System 36


1.9.6 Laboratory Control System 36


1.10 Electronic Records and Electronic Signatures 37


1.10.1 Electronic Records 37


1.10.2 Electronic Signatures 38


1.11 Employee Safety 38


1.11.1 Process Safety Information 39


1.11.2 Process Hazard Analysis 40


1.11.3 Operating Procedures 41


1.11.4 Training 41


1.11.5 New Facility Startup 41


1.11.6 Mechanical Integrity 42


1.11.7 Hot Work Permit 42


1.11.8 Management of Change 42


1.11.9 Incident Investigation 43


1.11.10 Emergency Planning and Response 43


1.11.11 Compliance Audits 43


1.12 US EPA 43


1.12.1 Clean Air Act 44


1.12.2 Safe Drinking Water Act 45


1.12.3 Resource Conservation and Recovery Act 46


1.12.4 Emergency Planning and Community Right?to?Know Act 47


1.12.5 Clean Water Act 48


1.13 Process Analytical Technology 49


1.13.1 Process Understanding 49


1.13.2 Principles and Tools 50


1.13.3 Strategy for Implementation 51


1.14 Conclusion 51


References 51


Further Reading 52


2 Pharmace

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