The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Bibliographic Details
Call Number:Libro Electrónico
Main Author: Rodríguez-Pérez, José (Pepe)
Format: Electronic eBook
Language:Inglés
Published: La Vergne : ASQ Quality Press, 2014.
Subjects:
Pharmaceutical industry > United States > Quality control.
Pharmaceutical industry > Production standards > United States.
Drugs > Standards.
Industrie pharmaceutique > États-Unis > Qualité > Contrôle.
Industrie pharmaceutique > Production > Normes > États-Unis.
Médicaments > Normes.
Drugs > Standards
Pharmaceutical industry > Quality control
United States
Online Access:Texto completo
Table of Contents:
  • Cover
  • Title page
  • CIP data
  • Table of Contents
  • List of Figures and Tables
  • Preface
  • List of Acronyms
  • Chapter 1-Introduction
  • Facts About cGMP
  • cGMP and the Quality System
  • Notes
  • Chapter 2-US Current Good Manufcturing Practice
  • cGMP and The FDA
  • Drugs Regulated by CDER
  • Foreign Manufacturers
  • Notes
  • Chapter 3-International Good Manufacturing Practice
  • The EU
  • Canada
  • Japan
  • Brazil
  • Australia
  • China
  • India
  • Korea
  • South Africa
  • Russia
  • New Zealand
  • Notes
  • Chapter 4-Global Good Manufacturing Practice Guides and Harmonization
  • The WHO
  • International Conference on Harmonization
  • Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme
  • Notes
  • Chapter 5-Details Analysis of the Requirements and Guidances
  • Part 210-Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs: General
  • Part 211-Current Good Manufacturing Practice for Finished Pharmaceuticals
  • Notes
  • Chapter 6-Missing Subparts
  • Corrective and preventive action system
  • Management Control
  • Process Validations
  • Notes
  • Chapter 7-What Are Inspectors Looking For?
  • Types of Inspections
  • Drug Manufacturing Inspections
  • Preapproval Inspection
  • API Inspections
  • Sterile Drug Process Inspection
  • Notes
  • Chapter 8-Quality at Risk: The Price of Noncompliance
  • Field Alerts
  • Recall Process for FDA-Regulated Products
  • Form 483
  • Regulatory Meetings
  • Dear Health Care Provider Letter
  • Untitled and Warning Letters
  • Criminal Investigations
  • Seizure
  • Injunctions
  • Consent Decrees and Disgorgements
  • Debarment and Disqualification List
  • Progressive Enforcement
  • Notes
  • Appendix-At-a-Glance Comparisons
  • Bibliography
  • Useful Websites

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