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The certified pharmaceutical GMP professional handbook
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Milwaukee, Wisconsin :
ASQ Quality Press,
2016.
|
| Edición: | Second edition. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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
- 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
- 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
- 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
- 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