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Item Detail

Regulatory Compliance Almanac

Author(s): Schnoll, Les

ISBN10: 0965044564

ISBN13: 9780965044561

Cover: Hardcover

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Dedication

Acknowledgments

About the Author

xiii

Introduction and Overview

(8)

The Federal Food, Drug, and Cosmetic Act of 1938

(3)

The Wiley Act and Subsequent Legislation

(1)

Violations and Penalties

(1)

Legal Precedents

(1)

The U.S. Food and Drug Administration

(1)

The Federal Insecticide, Fungicide, and Rodenticide Act

(2)

Good Laboratory Practices

(10)

Historical Precedents

(1)

The Philosophy Behind the Good Laboratory Practices

(1)

What are the GLPs?

(1)

GLP Scope and Intent

(1)

GLP Requirements

(6)

Types of Inspections

(1)

Pharmaceutical Good Manufacturing Practices

(10)

GMP Requirements

(10)

Process Validation

(12)

Process Validation

(3)

Process Capability

(1)

Process Validation Tools

(3)

Conducting Process Validation

(5)

Documentation Requirements

(12)

Documentation Requirements---Drugs

(2)

Documentation Requirements---Medical Devices

(1)

Drug Master Files

(7)

Electronic Records and Electronic Signatures

(3)

Complaint Investigation

(4)

The Designated Investigator

(1)

The Complaint Investigation Process

(3)

Food Good Manufacturing Practices

(4)

Current Good Food Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

(3)

Sanitation Compliance

(10)

Pesticides

(2)

Detergents and Sanitizers

(2)

Birds

(1)

Rodents

(1)

Microbiology

(1)

Insects

(1)

Sanitation Compliance Audit

(1)

Additional Regulations

(2)

Medical Device Good Manufacturing Practices

(12)

Classification of Medical Devices

(1)

Reclassification of Medical Devices

(1)

Pre-Market Notification for New Medical Devices

(1)

Requirements for All Medical Devices

(2)

The Quality System Regulation (Medical Device Good Manufacturing Practices)

(8)

Medical Device Reporting

(6)

Reporting Requirements

(2)

Procedures, Records, and Disclosure

(1)

Enforcement

(2)

The Medical Device Directives

(30)

The Medical Device Directive

(25)

Use of the CE Mark

114

(2)

The Active Implantable Medical Device Directive

116

(3)

The In-Vitro Diagnostic Device Directive

119

(10)

The In-Vitro Diagnostic Device Directive in General

119

(1)

Technical Documentation

119

(10)

Animal Welfare and the Institutional Animal Care and Use Committee

129

(8)

The History of the Animal Welfare Act

129

(1)

External Laws, Policies, and Regulations

130

(2)

Compliance Inspections

132

(2)

The Institutional Animal Care and Use Committee

134

(3)

Good Clinical Practices

137

(16)

Key Definitions

138

(1)

The Principles of Good Clinical Practice

138

(1)

The Institutional Review Board/Independent Ethics Committee

139

(2)

The Investigator

141

(3)

The Sponsor

144

(3)

The Monitor

147

(1)

Nonconformances Identified During Monitoring and Auditing

148

(1)

Clinical Trial Protocol and Protocol Amendments

149

(2)

Investigator's Brochure

151

(1)

Essential Documents for the Conduct of a Clinical Trial

152

(1)

Summary

153

(2)

APPENDIX 1---MILESTONES IN U.S. FOOD AND DRUG LAW HISTORY

155

(10)

APPENDIX 2---FEDERAL FOOD AND DRUGS ACT OF 1906

165

(10)

APPENDIX 3---COMPARISON OF THE EXPLICITY STATED GLP REQUIREMENTS

175

(4)

APPENDIX 4---PART 58: GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY Studies

179

(18)

APPENDIX 5---PART 160: GOOD LABORATORY PRACTICE STANDARDS

197

(14)

APPENDIX 6---PART 792: GOOD LABORATORY PRACTICE STANDARDS

211

(14)

APPENDIX 7---OECD PRINCIPLES OF GOOD LABORATORY PRACTICE

225

(22)

APPENDIX 8---CURRENT GOOD MANUFACTURING PRACTICES

247

(26)

Part 210: For Manufacturing, Processing, Packing, or Holding of Drugs; General

247

(2)

Part 211: For Finished Pharmaceuticals

249

(24)

APPENDIX 9---GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION

273

(10)

APPENDIX 10---``GENERIC'' MIXING PROCESS VALIDATION

283

(2)

APPENDIX 11---PART 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

285

(6)

APPENDIX 12---COMPLAINT INVESTIGATION

291

(2)

APPENDIX 13---PART 110: CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

293

(12)

APPENDIX 14---SANITATION COMPLIANCE AUDIT

305

(12)

APPENDIX 15---PART 820: QUALITY SYSTEM REGULATION

317

(16)

APPENDIX 16---SAMPLE FDA FORM 3500A

333

(2)

APPENDIX 17---FDA FORM 3500A: INSTRUCTIONS

335

(2)

APPENDIX 18---MEDICAL DEVICE DIRECTIVE CLASSIFICATION ROUTE CHART: NONINVASIVE CHART

337

(2)

APPENDIX 19---MEDICAL DEVICE DIRECTIVE CLASSIFICATION ROUTE CHART: INVASIVE CHART

339

(2)

APPENDIX 20---MEDICAL DEVICE DIRECTIVE CLASSIFICATION ROUTE CHART: ACTIVE CHART

341

(2)

APPENDIX 21---MEDICAL DEVICE DIRECTIVE ANNEX 1: ESSENTIAL REQUIREMENTS

343

(12)

APPENDIX 22---SAMPLE DECLARATION OF CONFORMITY

355

(2)

APPENDIX 23---ACTIVE IMPLANTABLE MEDICAL DEVICE DIRECTIVE ANNEX 1: ESSENTIAL REQUIREMENTS

357

(6)

APPENDIX 24---IN-VITRO DIAGNOSTIC MEDICAL DEVICE DIRECTIVE ANNEX 1: ESSENTIAL REQUIREMENTS

363

(12)

APPENDIX 25---ANIMAL WELFARE ACT

375

(18)

APPENDIX 26---SAMPLE ANIMAL WELFARE ASSURANCE STATEMENT

393

(10)

APPENDIX 27---SAMPLE RESEARCH ANIMAL VENDOR AUDIT REPORT

403

(6)

APPENDIX 28---ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

409

(10)

Glossary

419

(14)

Index

433

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