GOOD DRUG REGULATORY PRACTICES A Regulatory Affairs Quality Manual
Helene I. Dumitriu
Advisory Editor
Thomas O. Hintze
Interpharm Press, Inc. Buffalo Grove, Illinois
Contents
Foreword
ix
Preface
xi
Acknowledgments
xii
Introduction
xiii
Parti THE REGULATORY AFFAIRS QUALITY SYSTEM
1
Historical Overview
3
Why Regulatory Affairs? The Development of Drug Laws and Drug Regulations
3
United States of America European Union (EU) Japan
3 5
8
International Conference on Harmonisation (ICH) World Health Organization Summary
9
10
11
Regulatory Affairs: Development in the Pharmaceutical Industry Regulatory Affairs Professional Societies The British Institute of Regulatory Affairs (BIRA) The European Society of Regulatory Affairs (ESRA)
77 12
13 13
Central European Society for Regulatory Affairs (MEGRA— Mitteleuropaeische Gesellschaft fuer regulatorische Angelegenheiten e.V) 14
III
iv
Good Drug Regulatory Practices The Pan-European Federation of Regulatory Affairs Societies (PEFRAS) 14 The Regulatory Affairs Professionals Society (RAPS)
14
Good Practice and Quality Management: An Overview Good Manufacturing Practice Good Laboratory Practice Good Clinical Practice ISO 9000 Series
15
16 16
17
References
2
15
19
Good Regulatory Practice: The Application of Quality Management to Regulatory Affairs
23
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
23 26 29
History 29 Education 30 Scientific and Technical Experts Good Regulatory Practice 31 References
3
30 35
Check Your Quality System
37
Quality System Questionnaire
38
Conclusions from This Test
44
Part II THE REGULATORY AFFAIRS QUALITY MANUAL 4
The Quality Manual Explained
47
Introduction
47
Instructions for Use Distribution 47 Purpose and Scope
47 48
Regulatory Affairs Structure and Organization • Responsibility of Functional Units 48
48
Contents Regulatory Affairs Quality Policy
49
General Statement: Company Guidelines for Quality Management Regulatory Affairs Quality Policy Statement
50
52
The Quality Systems Outline
52
Notes
53
Appendix: Numbers and Titles of Policies and Standards in This Manual
55
Policies Standards
5
49
49
Details of Regulatory Affairs Structure and Organization Statement of Authority and Responsibility
v
55 56
The Philosophy Behind the Policies
57
Policy 01: The Policy on Policy
58
Policy 02: The Policy on Auditing and Compliance
58
Policy 03: The Policy on Application for Clinical Trial License
67
Policy 04: The Policy on Application for Marketing Authorization
63
Policy 05: The Policy on Archiving Management
79
Policy 06: The Policy on Change Alert/Authorization
Process
82
Policy 07: The Policy on Contact Report
84
Policy 08: The Policy on Contact with Regulatory Body
85
Policy 09: The Policy on Crisis Management
86
Policy 10: The Policy on Documents for Regulatory Purposes
89
Policy 11: The Policy on Dossier
94
Policy 12: The Policy on Education/Training
100
Policy 13: The Policy on Electronic Submission
107
Policy 14: The Policy on Environmental Protection
118
Policy 15: The Policy on Global Dossier
124
Policy 16: The Policy on Import/Export
130
Policy 17: The Policy on Information Management
131
Policy 18: The Policy on Information Technology
137
Policy 19: The Policy on Inspection
137
vi
6
Good Drug Regulatory Practices Policy 20: The Policy on Labeling
140
Policy 21: The Policy on Outsourcing
143
Policy 22: The Policy on Periodic Safety Update Report
144
Policy 23: The Policy on Project Assignments
145
Policy 24: The Policy on Promotion/Advertising Compliance
145
Policy 25: The Policy on Regulations and Guidelines
146
Policy 26: The Policy on Regulatory Strategy
150
Policy 27: The Policy on Submission
154
Policy 28: The Policy on Terminology
159
Policy 29: The Policy on Tools
7 62
Policies
165
01: The Policy on Policy
166
02: The Policy on Auditing and Compliance
174
03: The Policy on Application for Clinical Trial License
180
04: The Policy on Application for Marketing Authorization
183
05: The Policy on Archiving Management
186
06: The Policy on Change Alert/Authorization Process
190
07: The Policy on Contact Report
195
08: The Policy on Contact with Regulatory Body
198
09: The Policy on Crisis Management
202
10: The Policy on Documents for Regulatory Purposes
206
11: The Policy on Dossier
210
12: The Policy on Education/Training
214
13: The Policy on Electronic Submission
220
14: The Policy on Environmental Protection
223
15: The Policy on Global Dossier
227
16: The Policy on Import/Export
231
17: The Policy on Information Management
234
18: The Policy on Information Technology
240
19: The Policy on Inspection
245
Contents
7
vii
20: The Policy on Labeling
248
21: The Policy on Outsourcing
251
22: The Policy on Periodic Safety Update Report
254
23: The Policy on Project Assignments
257
24: The Policy on Promotion/Advertising Compliance
260
25: The Policy on Regulations and Guidelines
263
26: The Policy on Regulatory Strategy
268
27: The Policy on Submission
271
28: The Policy on Terminology
275
29: The Policy on Tools
278
Standards
281
01.01: A Standard for Policy
282
01.02: A Standard for Standard Operating Procedure
285
03.01: A Standard for U.S. Application for Clinical Trial License: IND Content and Format
288
04.01: A Standard for EU Application for Marketing Chemical Active Substance(s)
Authorization: 293
04.02: A Standard for EU Application for Marketing
Authorization:
Biological(s), Part II
302
04.03: A Standard for U.S. Application for Marketing Authorization 312 07.01: A Standard for Regulatory Body Contact Report
