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

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WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report ■■ ■■ ■■ dissolution test (paddle apparatus, UV-Vis absorption spectrophotometry); water determination by Karl Fischer titration; related substances by HPLC. The Expert Committee reviewed the proposal and adopted the test techniques for Phase 6. There was also a discussion on the possibility of using the opportunity of testing for monitoring quality of the products on the respective national markets in cases where the laboratories met the required standards of performance. This, however, would be outside the scope of the EQAAS. WHO Technical Report Series, No. 981, 2013 20
6. Quality assurance – good manufacturing practices 6.1 Updates of WHO GMP texts In 2011 the Expert Committee approved updates to three GMP texts. The secretariat reported that no proposals for updating of GMP materials had been received since then. It was noted, however, that a number of European Union (EU) and United States Food and Drug Administration (US-FDA) GMP guidelines had been recently updated. The Expert Committee requested the secretariat to make a proposal on how to revise the WHO guidelines in light of these trends in other new guidelines. 6.2 Training materials The process for the revision of the WHO training modules was approved by the Expert Committee in October 2011 to bring them in line with the updated guidelines. Each slide of the modules was therefore checked for correctness in relation to the various revised GMP texts. All basic training modules had been revised and updated and were being reviewed. Major changes were made to the GMP training modules, e.g. for the module on quality management, to include risk assessment and other new factors. The Expert Committee was informed that there was currently no training material on microbiology laboratories and hazardous materials as these GMP texts had only been developed in recent years. A number of other training modules were still under revision. It was noted that all WHO GMP guidelines are to be provided on a CD-ROM. The Expert Committee expressed its gratitude for the update. 21
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
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Page 16 and 17: 2. General policy 2.1 Cross-cutting
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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 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 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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