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|b C456 2016
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|a 615.1/9
|2 23
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| 049 |
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|a UAMI
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| 245 |
0 |
4 |
|a The certified pharmaceutical GMP professional handbook
|h [electronic resource] /
|c Mark Allen Durivage, editor.
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| 250 |
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|a Second edition.
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| 264 |
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1 |
|a Milwaukee, Wisconsin :
|b ASQ Quality Press,
|c 2016.
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| 300 |
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|a 1 online resource
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| 504 |
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|a Includes bibliographical references (pages 451-459) and index.
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| 505 |
0 |
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|a Intro -- Title Page -- CIP Data -- Table of Contents -- List of Figures and Tables -- Acronyms and Abbreviations -- Preface -- Acknowledgments -- Part I: Regulatory Agency Governance -- Chapter 1: Global Regulatory Framework -- United States Federal Statutes Relevant to Pharmaceuticals -- The Administrative Procedure Act -- United States Federal Food, Drug, and Cosmetic Act -- United States Public Health Service Act -- The Virus-Serum-Toxin Act -- European Union's Legal System Relevant to Pharmaceuticals -- Japan's Legal System Relevant to Pharmaceuticals
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| 505 |
8 |
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|a China's Legal System Relevant to Pharmaceuticals -- India's Legal System Relevant to Pharmaceuticals -- Chapter 2: Regulations and Guidances -- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) -- Health Canada -- World Health Organization (WHO) -- International Conference on Harmonization -- European Medicines Agency (EMA) -- The United States Food and Drug Administration -- Therapeutic Goods Administration (TGA) -- United States Department of Agriculture (USDA) 9 CFR-Animals and Animal Products -- USDA Veterinary Service Memorandum No. 800.65
|
| 505 |
8 |
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|a International Pharmaceutical Excipients Council -- Japanese Ministry of Health, Labour, and Welfare (MHLW) -- Chapter 3: Mutual Recognition Agreements -- Mutual Recognition Agreements -- MRAs Established by the European Union and Partner Countries -- Key Elements of Mutual Recognition Agreements -- Pharmaceutical Inspection Co-operation Scheme -- Chapter 4: Regulatory Inspections -- Inspection Authority -- Types of Inspections -- Sharing of Inspection Findings -- Inspections of Foreign Drug Manufacturers -- Reviewing Documents -- Validation -- Cultural Aspects
|
| 505 |
8 |
|
|a Documentation of Violations of cGMPs -- Inspection Techniques -- Inspection Process of a U.S. Firm -- Chapter 5: Enforcement Actions -- Types of Enforcement Actions -- Notice of Observations/Violations -- FDA Untitled Letters -- Warning Letters -- Product Seizures -- Injunctions -- Loss of Marketing License -- Loss of Establishment License -- Debarment -- Voluntary Actions -- Chapter 6: Regulatory Agency Reporting -- Planned Changes -- Evaluating Post-Marketing Changes -- Technical Assessment -- Analytical Assessment -- Equivalence Assessment -- Adverse Effect -- Reporting Strategy
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| 505 |
8 |
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|a Regulatory Reporting Requirements -- Planned Changes -- Unplanned Events -- Chapter 7: Site Master File (SMF), ValidationMaster Plan (VMP), Drug Master File(DMF), and Site Reference File (SRF) -- Site Master File -- Content of Site Master Files -- Validation Master Plan (VMP) and Master Validation Plan (MVP) -- Drug Master File -- Types of Drug Master Files -- Changes to Drug Master Files -- Preparing a Site Master File (SMF) -- Content of Site Master File -- Appendixes -- Part II: Quality Systems -- Chapter 8: Quality Management System -- Establishing a Quality Management System
|
| 590 |
|
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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| 650 |
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0 |
|a Pharmaceutical industry
|x Quality control.
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| 650 |
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0 |
|a Drug development.
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| 650 |
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|a Drugs
|x Standards.
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| 650 |
|
6 |
|a Industrie pharmaceutique
|x Qualité
|x Contrôle.
|
| 650 |
|
6 |
|a Médicaments
|x Développement.
|
| 650 |
|
6 |
|a Médicaments
|x Normes.
|
| 650 |
|
7 |
|a Drug development
|2 fast
|
| 650 |
|
7 |
|a Drugs
|x Standards
|2 fast
|
| 650 |
|
7 |
|a Pharmaceutical industry
|x Quality control
|2 fast
|
| 700 |
1 |
|
|a Durivage, Mark Allen,
|e editor.
|
| 758 |
|
|
|i has work:
|a The certified pharmaceutical GMP professional handbook (Text)
|1 https://id.oclc.org/worldcat/entity/E39PCYcDTXYRyxRwXy8CTyVtJC
|4 https://id.oclc.org/worldcat/ontology/hasWork
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|z 9780873899338
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|w (DLC) 2016011717
|w (OCoLC)945585836
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|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=6264135
|z Texto completo
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|a Askews and Holts Library Services
|b ASKH
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