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

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SELECTED WHO PUBLICATIONS OF RELATED INTEREST The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO's constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications. The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers. These books are closely tied to the Organization's priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO’s Member countries and the collaboration of world leaders in public health and the biomedical sciences. To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation. By helping to promote and protect health and prevent and control disease throughout the world, WHO's books contribute to achieving the Organization's principal objective – the attainment by all people of the highest possible level of health. The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO. For further information, please contact WHO Press, World Health Organization; 1211 Geneva 27, Switzerland; www.who.int/bookorders; tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int. The International Pharmacopoeia, fourth edition. Volume 1: general notices; monographs for pharmaceutical substances (A–O) Volume 2: monographs for pharmaceutical substances (P–Z); monographs for dosage forms and radiopharmaceutical preparations; methods of analysis; reagents. 2006 (1500 pages), also available on CD-ROM and online First supplement: general notices; monographs for pharmaceutical substances; monographs for dosage forms; general and specific monographs; methods of analysis; International Chemical Reference Substances; International Infrared Reference Spectra; reagents, test solutions and volumetric solutions. 2008 (309 pages), also available on CD-ROM and online Second supplement: general notices; monographs for pharmaceutical substances and radiopharmaceuticals; monographs for dosage forms; general and specific monographs; methods of analysis; International Chemical Reference Substances; International Infrared Reference Spectra; reagents, test solutions and volumetric solutions. 2011 (CD-ROM and online) Basic tests for drugs: pharmaceutical substances, medicinal plant materials and dosage forms 1998 (94 pages) Basic tests for pharmaceutical dosage forms 1991 (134 pages) Quality Assurance of Pharmaceuticals: a compendium of guidelines and related materials Updated, comprehensive edition, 2011 (CD-ROM and online) Also available on: WHO training modules on GMP. A resource and study pack for trainers, 2007 (CD-ROM). WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-sixth report. WHO Technical Report Series, No. 970, 2012 (235 pages) International Nonproprietary Names (INN) for pharmaceutical substances Cumulative List No. 14 2011 (available on CD-ROM only) The Selection and Use of Essential Medicines Report of the WHO Expert Committee (including the 17th WHO Model List of Essential Medicines and the 3rd WHO Model List of Essential Medicines for Children) WHO Technical Report Series, No. 965, 2011 (263 pages) WHO Expert Committee on Biological Standardization Fifty-seventh report. WHO Technical Report Series, No. 964, 2012 (228 pages) Further information on these and other WHO publications can be obtained from WHO Press, World Health Organization, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int; order online: http://www.who.int/bookorders)
W H O T e c h n i c a l R e p o r t S e r i e s 9 8 1 WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization
Page 1: The Expert Committee on Specificati
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 13: WHO Expert Committee on Specificati
Page 16 and 17: 2. General policy 2.1 Cross-cutting
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
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WHO Expert Committee on Specificati
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WHO Technical Report Series, No. 98
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Annex 1 Release procedure for Inter
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Annex 2 WHO guidelines on quality r
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Annex 2 While the choice of the too
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Annex 2 ■■ The level of effort,
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Annex 2 within companies and, where
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Annex 2 risk analysis The estimatio
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Annex 2 3.3 Knowledge of the produc
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Annex 2 During risk control activit
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Annex 2 diagrams and appropriate re
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Annex 2 Similarly, contract staff m
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Annex 2 4.5 QRM application during
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Annex 2 Among others, QRM methodolo
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Annex 2 ■■ ■■ ■■ ■■
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Annex 2 All documentation related t
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Annex 2 6. Risk management tools A
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Annex 2 This table is a very basic
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Annex 2 Table 3 continued Risk mana
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Annex 3 WHO guidelines on variation
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Annex 3 3.2. P.5 Control of FPP 142
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Annex 3 to implementation, assessme
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Annex 3 WHO/PQP should be notified
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Annex 3 2.1.2 Minor variation (Vmin
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Annex 3 active pharmaceutical ingre
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Annex 3 Table continued Description
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Annex 3 Table continued Documentati
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Annex 3 Table continued Conditions
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Annex 3 3.2. P.8 Stability Descript
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Annex 3 Appendix 1 Examples of chan
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Annex 4 Collaborative procedure bet
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Annex 4 ■■ ■■ ■■ associ
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Annex 4 3.2 WHO/PQP and participati
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Annex 4 3.7 The decision whether or
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Annex 4 that a WHO-prequalified pro
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Annex 4 Figure 1 Flowchart showing
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Annex 4 Figure 1 continued Post-reg
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Annex 4 5.5 WHO/PQP removes a produ
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Annex 4 such Product that it will a
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Annex 4 Timelines In respect of eac
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Annex 4 Title in NMRA: E-mail: Phon
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Annex 4 secret access code and from
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Annex 4 Appendix 2 Consent of WHO p
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Annex 4 Appendix 3 Expression of in
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Annex 4 -- information and document
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Annex 4 Date of prequalification (d
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Annex 4 Appendix 4 Report on post-r
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WHO Technical Report Series, No. 981 - World Health Organization

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