Good Drug Regulatory Practice (GDRP)

This book attempts to be the first systematic treatment on what should now be named Good Drug Regulatory Practice (GDRP). For many years, experienced Regulatory Affairs professionals have asked for a guide to the quality management of their work. Thus, this Regulatory Affairs Quality Manual was planned and written

to meet this need. It is intended to serve as a reliable and useful source of information and background knowledge on the relationship between the quality of regulatory affairs work and the quality obtained and maintained of regulatory (e.g., marketing) authorizations. It will be a source of reference for Regulatory Affairs

professionals as well as for quality controllers, who need information on the relationship between the work of Regulatory Affairs and quality in medicinal product development. However, this book does not contain information easily accessible elsewhere  and/or likely to require frequent updates (e.g., addresses of

Regulatory Bodies). The book covers regulatory affairs regarding global product development for the European Union, Japan, and the United States.

Part I presents a theoretical basis for quality management. 

1.0 Historical Overview

--WHY REGULATORY AFFAIRS? THE DEVELOPMENT OF DRUG LAWS AND DRUG REGULATIONS

--REGULATORY AFFAIRS: DEVELOPMENT IN THE PHARMACEUTICAL INDUSTRY

--REGULATORY AFFAIRS PROFESSIONAL SOCIETIES

--GOOD PRACTICE AND QUALITY MANAGEMENT: AN OVERVIEW

--Good Manufacturing Practice

2.0 Good Regulatory Practice: The Application of Quality Management to Regulatory Affairs

-- GOOD REGULATORY PRACTICE: A PROPOSAL FOR A QUALITY SYSTEM

-- GOOD REGULATORY PRACTICE: A PROPOSAL FOR A QUALITY SYSTEM FOR REGULATORY BODIES

-- GOOD REGULATORY PRACTICE: THE ROLE OF REGULATORY AFFAIRS IN PRODUCT DEVELOPMENT

3.0 Check Your Quality System

-- QUALITY SYSTEM QUESTIONNAIRE

PART-II THE REGULATORY AFFAIRS QUALITY MANUAL

4.0 The Quality Manual Explained

-- INTRODUCTION

-- REGULATORY AFFAIRS QUALITY POLICY

-- THE QUALITY SYSTEM'S OUTLINE

-- NOTES

-- APPENDIX: NUMBERS AND TITLES OF POLICIES AND STANDARDS IN THIS MANUAL

5.0 The Philosophy Behind the Policies

POLICY 01. THE POLICY ON POLICY

POLICY 02. THE POLICY ON AUDITING AND COMPLIANCE

POLICY 03. THE POLICY ON APPLICATION FOR CLINICAL TRIAL LICENSE

POLICY 04. THE POLICY ON APPLICATION FOR MARKETING AUTHORIZATION

POLICY 05. THE POLICY ON ARCHIVING MANAGEMENT

POLICY 06. THE POLICY ON CHANGE ALERT I AUTHORIZATION PROCESS

POLICY 07. THE POLICY ON CONTACT REPORT

POLICY 08. THE POLICY ON CONTACT WITH REGULATORY BODY

POLICY 09. THE POLICY ON CRISIS MANAGEMENT

POLICY 10. THE POLICY ON DOCUMENTS FOR REGULATORY PURPOSES

POLICY 11. THE POLICY ON DOSSIER

POLICY 12. THE POLICY ON EDUCATION/TRAINING

POLICY 13. THE POLICY ON ELECTRONIC SUBMISSION

POLICY 14. THE POLICY ON ENVIRONMENTAL PROTECTION

POLICY 15. THE POLICY ON GLOBAL DOSSIER

POLICY 16. THE POLICY ON IMPORT /EXPORT

POLICY 17. THE POLICY ON INFORMATION MANAGEMENT

POLICY 18. THE POLICY ON INFORMATION TECHNOLOGY

POLICY 19. THE POLICY ON INSPECTION

POLICY 20. THE POLICY ON LABELING

POLICY 21. THE POLICY ON OUTSOURCING

POLICY 22. THE POLICY ON PERIODIC SAFETY UPDATE REPORT

POLICY 23. THE POLICY ON PROJECT ASSIGNMENTS

POLICY 24. THE POLICY ON PROMOTION/ADVERTISING COMPLIANCE

POLICY 25. THE POLICY ON REGULATIONS AND GUIDELINES

POLICY 26. THE POLICY ON REGULATORY STRATEGY

POLICY 27. THE POLICY ON SUBMISSION

POLICY 28. THE POLICY ON TERMINOLOGY

POLICY 29. THE POLICY ON TOOLS

6.0 Policies

-- Policy 

-- Auditing and Compliance

-- Application for Clinical Trial License

-- Application for Marketing Authorization

-- Archiving Management

-- Change Alert/ Authorization Process

-- Contact Report

-- Contact with Regulatory Body

-- Crisis Management

-- Documents for Regulatory Purposes

-- Dossier

-- Education/Training

-- Electronic Submission

-- Environmental Protection

-- Global Dossier

-- Import/Export

-- Information Management

-- Information Technology

-- Inspection

-- Labeling

-- Outsourcing

-- Periodic Safety Update Report

-- Project Assignments

-- Promotion/ Advertising Compliance

-- Regulations and Guidelines

-- Regulatory Strategy

-- Submission

-- Terminology

-- Tools

7.0 Standards

-- Policy

-- Standard Operating Procedure

-- U.S. Application for Clinical Trial License: IN D Content and Format

-- EU Application for Marketing Authorization: Chemical Active Substance(s)

-- EU Application for Marketing Authorization: Biological(s), Part II

-- U.S. Application for Marketing Authorization

-- Regulatory Body Contact Report

-- Regulatory Document Types

-- Dossier

-- Global Dossier

-- Labeling

-- Submission

-- Terminology

Glossary

Index