WHO Technical Report Series, No. 981 - World Health Organization

More documents

Recommendations

Info

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report WHO Technical Report Series, No. 981, 2013 56 Public Health, Nonthaburi, Thailand; Mr R. Tribe, Holder, ACT, Australia; Associate Professor Trinh Van Lau, Director, National Institute of Drug Quality Control, Hanoi, Viet Nam; Professor Tu Guoshi, National Institute for the Control of Pharmaceutical and Biological Products, Ministry of Public Health, Beijing, People’s Republic of China; Dr C. Tuleu, Senior Lecturer and Deputy Director, Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London, London, England; Dr Richard Turner, British Pharmacopoeia Commission, Medicines and Healthcare Products Regulatory Agency, London, England; United States of America Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA; United States of America Food and Drug Administration, Office of Pediatric Therapeutics, Office of the Commissioner, Rockville, MD, USA; Ms E. Uramis, GMP Advisor, Oficina Central Polo Científico, La Havana, Cuba; Dr A.R.T. Utami, National Agency for Drugs and Food Control, Jakarta Pusat, Indonesia; Mrs M. Vallender, Editor-in-Chief, British Pharmacopoeia Commission Secretariat, London, England; Mr M. van Bruggen, EU Liaison – Regulatory Intelligence, F. Hoffmann-La Roche, Basel, Switzerland; Mr F. Vandendriessche, Merck, Sharp and Dohme Europe, Brussels, Belgium; Dr J.E. van Oudtshoorn, Pretoria, South Africa; Dr A.J. van Zyl, Cape Town, South Africa; Mr A. Vezali Montai, Specialist in Regulation and GMP, Agência Nacional de Vigilância, Brasília, Brazil; Mrs L. Vignoli, Regulatory Affairs, Pharmaceuticals and Cosmetics, Roquette Cie, Lestren, France; Dr O. del Rosario Villalva Rojas, Executive Director, Quality Control Laboratories, National Quality Control Center, National Institute of Health, Lima, Peru; Mr L. Viornery, Agence nationale de sécurité du médicament et des produits de santé, Saint Denis, France; Dr L. Virgili, USA; Mr Wang Ju, Deputy Commissioner, Dalian Food and Drug Administration, Dalian, Liaoning, People's Republic of China; Mr P. Wang, Deputy Secretary-General, Chinese Pharmacopoeia Commission, Beijing, People’s Republic of China; Dr G. Wang'ang'a, Head, Microbiological and Medical Devices Units, National Quality Control Laboratory, Nairobi, Kenya; Dr A. Ward, Regulatory Affairs, Avecia Vaccines, Billingham, England; Dr D. Waters, Acting Scientific Operations Advisor, Office of Laboratories and Scientific Services, Therapeutic Goods Administration, Woden, ACT, Australia; Dr W. Watson, Associate Manager, CMC Regulatory Affairs, Gilead Sciences International, Cambridge, England; Dr D.E. Webber, Director-General, World Self-Medication Industry, Ferney-Voltaire, France; Professor W. Wieniawski, Polish Pharmaceutical Society, Warsaw, Poland; Dr S. Wolfgang, US Food and Drug Administration, Silver Spring, MD, USA; Mr E. Wondemagegnehu Biwota, Addis Ababa, Ethiopia; World Self-Medication Industry, Ferney-Voltaire, France; Dr B. Wright, Group Manager, GMP/GDP, North East Region, Medicines Inspectorate, Medicines and Healthcare Products Regulatory Agency, York, England; Ms X. Wu, Counsellor, Intellectual Property Division, World Trade Organization, Geneva, Switzerland;
Acknowledgements Professor Z.-Y. Yang, Guangzhou Municipal Institute for Drug Control, Guangzhou, People’s Republic of China; Professor Z.-Y. Yang, Member, United States Pharmacopeia International Health Expert Committee, Rockville, MD, USA; Dr D. Yi, Scientist, US Pharmacopeia, Rockville, MD, USA; Dr H. Yusufu, National Agency for Food and Drug Administration and Control, Abuja, Nigeria; Dr M. Zahn, Keltern, Germany; Dr H. Zhang, GMP Department Head, Center for Certification & Evaluation, Shanghai Food and Drug Administration, Shanghai, People's Republic of China; Dr T. Zimmer, CD Safety, Quality & Environmental Protection, Boehringer Ingelheim, Ingelheim, Germany; Dr N. Zvolinska, Deputy Director, Pharmaceutical Department, State Pharmacological Centre, Ministry of Health, Kiev, Ukraine; Mrs M. Zweygarth, Consultant, Geneva, Switzerland. 57
Page 1 and 2:
The Expert Committee on Specificati
Page 3 and 4:
W H O T e c h n i c a l R e p o r t
Page 5 and 6:
Contents WHO Expert Committee on Sp
Page 7 and 8:
12.4 Proposal for a procedure on sa
Page 9 and 10:
WHO Expert Committee on Specificati
Page 11 and 12:
Page 13:
Page 16 and 17:
2. General policy 2.1 Cross-cutting
Page 18 and 19:
Page 20 and 21: WHO Expert Committee on Specificati
Page 28 and 29: 4. Quality control - International
Page 36 and 37: 7. Quality assurance - new approach
Page 42 and 43: 9. Prequalification of priority ess
Page 44 and 45: 11. Prequalification of quality con
Page 50 and 51: 14. Miscellaneous 14.1 Quality assu
Page 58 and 59: WHO Technical Report Series, No. 98
Page 73 and 74: Annex 1 Release procedure for Inter
Page 75 and 76: Annex 2 WHO guidelines on quality r
Page 77 and 78: Annex 2 While the choice of the too
Page 79 and 80: Annex 2 ■■ The level of effort,
Page 81 and 82: Annex 2 within companies and, where
Page 83 and 84: Annex 2 risk analysis The estimatio
Page 85 and 86: Annex 2 3.3 Knowledge of the produc
Page 87 and 88: Annex 2 During risk control activit
Page 89 and 90: Annex 2 diagrams and appropriate re
Page 91 and 92: Annex 2 Similarly, contract staff m
Page 93 and 94: Annex 2 4.5 QRM application during
Page 95 and 96: Annex 2 Among others, QRM methodolo
Page 97 and 98: Annex 2 ■■ ■■ ■■ ■■
Page 99 and 100: Annex 2 All documentation related t
Page 101 and 102: Annex 2 6. Risk management tools A
Page 103 and 104: Annex 2 This table is a very basic
Page 105 and 106: Annex 2 Table 3 continued Risk mana
Page 107 and 108: Annex 3 WHO guidelines on variation
Page 109 and 110: Annex 3 3.2. P.5 Control of FPP 142
Page 111 and 112: Annex 3 to implementation, assessme
Page 113 and 114: Annex 3 WHO/PQP should be notified
Page 115 and 116: Annex 3 2.1.2 Minor variation (Vmin
Page 117 and 118: Annex 3 active pharmaceutical ingre
Page 119 and 120: Annex 3 Table continued Description
Page 121 and 122:
Annex 3 Table continued Documentati
Page 123 and 124:
Annex 3 Table continued Description
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Annex 3 Table continued Conditions
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Annex 3 3.2. P.8 Stability Descript
Page 167 and 168:
Annex 3 Appendix 1 Examples of chan
Page 169 and 170:
Annex 4 Collaborative procedure bet
Page 171 and 172:
Annex 4 ■■ ■■ ■■ associ
Page 173 and 174:
Annex 4 3.2 WHO/PQP and participati
Page 175 and 176:
Annex 4 3.7 The decision whether or
Page 177 and 178:
Annex 4 that a WHO-prequalified pro
Page 179 and 180:
Annex 4 Figure 1 Flowchart showing
Page 181 and 182:
Annex 4 Figure 1 continued Post-reg
Page 183 and 184:
Annex 4 5.5 WHO/PQP removes a produ
Page 185 and 186:
Annex 4 such Product that it will a
Page 187 and 188:
Annex 4 Timelines In respect of eac
Page 189 and 190:
Annex 4 Title in NMRA: E-mail: Phon
Page 191 and 192:
Annex 4 secret access code and from
Page 193 and 194:
Annex 4 Appendix 2 Consent of WHO p
Page 195 and 196:
Annex 4 Appendix 3 Expression of in
Page 197 and 198:
Annex 4 -- information and document
Page 199 and 200:
Annex 4 Date of prequalification (d
Page 201 and 202:
Annex 4 Appendix 4 Report on post-r
show all

WHO Technical Report Series, No. 981 - World Health Organization

Create successful ePaper yourself

Delete template?

Save as template?