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

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WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report Appendix 2 Changes to excipients Excipient Percentage excipient (w/w) out of total target dosage form core weight Filler ± 5.0 Disintegrant • starch • other ± 3.0 ± 1.0 Binder ± 0.5 Lubricant • Ca or Mg Stearate • other Glidant • talc • other ± 0.25 ± 1.0 ± 1.0 ± 0.1 WHO Technical Report Series No. 981, 2013 ■■ ■■ These percentages are based on the assumption that the active pharmaceutical ingredient (API) in the finished pharmaceutical product (FPP) is formulated to 100.0% of label/potency declaration. The total additive effect of all changes to excipients should be not more than 5.0% relative to the target dosage form weight (e.g. in a product consisting of API, lactose, microcrystalline cellulose and magnesium stearate, the lactose increases by 2.5% and microcrystalline cellulose decreases by 2.5%). If an excipient serves multiple functions (e.g. microcrystalline cellulose as a filler and as a disintegrant), then the most conservative recommended range should be applied (e.g. ± 1.0% for microcrystalline cellulose should be applied in this example). If a wider range is proposed, scientific justification and supporting data should be provided to demonstrate that the wider range will not affect the other function of the excipient. 154
Annex 4 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 1. Definitions 156 2. Background information 156 3. Principles of collaboration 158 4. Steps in the collaboration for national registration of a pharmaceutical product 163 5. Collaboration mechanisms for post-registration variations 168 6. Withdrawals, suspensions or delistings of prequalified pharmaceutical products and national deregistrations 169 Appendix 1. NMRA participation agreement and undertaking for NMRA focal point(s) 170 Appendix 2. Consent of WHO prequalification holder for WHO to share information with NMRA confidentially under the Procedure 179 Appendix 3. Expression of interest to NMRA for the assessment and accelerated national registration, acceptance by NMRA and notification of procedure outcomes 181 Appendix 4. Report on post-registration actions in respect of a product registered under the Procedure 187 155
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The Expert Committee on Specificati
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W H O T e c h n i c a l R e p o r t
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Contents WHO Expert Committee on Sp
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12.4 Proposal for a procedure on sa
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WHO Expert Committee on Specificati
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2. General policy 2.1 Cross-cutting
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4. Quality control - International
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7. Quality assurance - new approach
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9. Prequalification of priority ess
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11. Prequalification of quality con
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14. Miscellaneous 14.1 Quality assu
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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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WHO Technical Report Series, No. 981 - World Health Organization

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