| Description |
1 online resource (391 p.) |
| 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 |
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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? |
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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 |
| Notes |
Description based upon print version of record |
|
Index |
| Subject |
Pharmaceutical industry -- United States -- Quality control
|
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Pharmaceutical industry -- Production standards -- United States
|
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Drugs -- Standards.
|
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Drugs -- Standards
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Pharmaceutical industry -- Quality control
|
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United States
|
| Form |
Electronic book
|
| ISBN |
9780873898287 |
|
0873898281 |
|
