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

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WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report early 2012, the Committee encouraged further collaboration between the world's pharmacopoeias leading to harmonization of their work. A full list of the decisions and recommendations made by the Expert Committee at its forty-seventh meeting is given below. The following new guidelines were adopted and recommended for use: ■■ Release procedure for International Chemical Reference Substances (Annex 1) ■■ WHO guidelines on quality risk management (Annex 2) ■■ WHO guidelines on variations to a prequalified product (Annex 3) ■■ Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products (Annex 4) For inclusion in The International Pharmacopoeia The following monographs were adopted: ■■ for antiretroviral medicines WHO Technical Report Series, No. 981, 2013 ■■ ■■ –– abacavir sulfate –– abacavir oral solution –– nevirapine –– nevirapine oral suspension –– nevirapine tablets –– tenofovir disoproxil fumarate for antimalarial medicines –– artesunate –– artesunate tablets –– artesunate for injection –– artemisinin –– mefloquine hydrochloride for antituberculosis medicines –– cycloserine –– cycloserine capsules 38
Summary and recommendations ■■ for anti-infectives –– cloxacillin sodium –– pyrantel oral suspension ■■ for other medicines –– levonorgestrel and ethinylestradiol tablets –– zinc acetate –– zinc gluconate ■■ suppression of monographs –– artemisinin tablets –– artemisinin capsules ■■ for harmonized general texts –– dissolution test for solid oral dosage forms (based on PDG text) ■■ general policy topics and general revision issues for: –– capsules –– parenteral preparations –– uniformity of content for single-dose preparations –– high-performance liquid chromatography ■■ supplementary information section: –– resistance to crushing of tablets –– measurement of consistency by penetrometry –– softening time determination of lipophilic suppositories. ■■ The Committee adopted the following new ICRS: –– atenolol ICRS; –– azobenzene melting point ICRS; –– ciprofloxacin ICRS; –– dacarbazine ICRS; –– erythromycin ethylsuccinate ICRS; –– niridazole ICRS; –– phenobarbital ICRS; 39
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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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
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Page 89 and 90: Annex 2 diagrams and appropriate re
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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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