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

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WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report International Nonproprietary Names Programme (INN), QSM Dr R.G. Balocco, Manager Prequalification Programme, QSM Dr J. Sabartova Dr M. Smid Medicines Access and Rational Use (EMP/MAR) 9 Traditional Medicine (Health Policy, Development and Services (HDS)/TRM) 9 Quality, Safety and Standards (Immunization, Vaccines and Biologicals (IVB)/QSS) 9 Mr David Bramley (report writer) Special acknowledgement and appreciation is given to Dr J.A. Molzon, Associate Director for International Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA, who attended as observer in her function as member of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. WHO Technical Report Series, No. 981, 2013 9 Unable to attend. x
WHO Expert Committee on Specifications for Pharmaceutical Preparations Declarations of interest Members of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and temporary advisers reported the following: Professor S. Bawazir, Professor T. Dekker, Ms N. Guerrero Rivas, Professor J. Hoogmartens, Professor S. Jin, Ms M.Y. Low, Ms C. Munyimba-Yeta, Dr L. Paleshnuik, Ms M.-L. Rabouhans and Dr J.-L. Robert reported no conflicts of interest. Professor H.G. Kristensen reported that he and his wife, a former employee of Novo Nordisk, hold investment interests in the company. Professor Kristensen has provided an expert opinion and testimony as an independent expert in patent cases regarding the formulation and processing of medicines. The declaration did not conflict with the subjects of the meeting. Ms G.N. Mahlangu reported that she would receive an out-of-pocket allowance from the Medicines Control Authority of Zimbabwe in accordance with the travel allowances schedule for sponsored travel. Dr S. Parra reported that she is a full-time employee of a governmental organization (Canadian Ministry of Health) and, as such, is a civil servant receiving remuneration from a regulatory agency. Dr Parra works for the department that approves new medicines for the Canadian market. As an employee of Health Canada she represents her organization in international forums and was present in sessions on topics relevant to her work (i.e. evaluation of the quality part of drug applications) as a stakeholder. Professor A.J. Nunn reported that he took part in discussions of the paediatric hospital pharmacy practice for Rosemont Pharmaceuticals, for which he personally received payment in 2012. His research unit received a research grant in 2011 of £250 000 from the United Kingdom National Institute for Health Research; a research grant “GRIP” WP5 from EU FP7 for the current year of €6 million (part-consortium); and personal conference costs in 2011 from the European Paediatric Formulations Initiative. He is a member of the European Medicines Agency (EMA) Paediatric Committee (PDCO) and PDCO Formulation Working Party, considering formulation development for paediatric investigation parties and for guidelines (2010–2014). Professor Nunn was not present in any Expert Committee session during which individual products were discussed. Dr A.J. van Zyl reported that he received the fees for the current year for consulting for the United States Pharmacopeia (USP), the Global Fund, and pharmaceutical companies. He has provided an expert opinion on good manufacturing practices (GMP) in an arbitration case for Norton Rose, Cape Town, South Africa, from August 2011 to date. The declarations of interest were presented to the Expert Committee for information. There were no comments from Committee members or temporary advisers. xi
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
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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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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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