上海cmc培訓(xùn)postapprovalchangesforfinishedproduct-資料下載頁
2025-10-10 08:32本頁面
【正文】 . I, II, III…) ? “x” refers to the letter of the subsection inside a chapter where the variation is included (. a, b, c…) ? “n” refers to the number given in the Annex to this Guideline to a specific variation (. 1, 2, 3…) AAPS/CPA Workshop, June 2829, 2021 15 Few Examples Changes in Formulation Changes US EU (old) EU (new) Flavoring or coloring system Addition , deletion or replacement AR/CEB/CEB30 IA/IB IAIN Ingredients Qualitative or quantitative changes PAS II IA/II AAPS/CPA Workshop, June 2829, 2021 16 Few Examples Changes in Process Changes US EU (old) EU (new) Dry to wet granulation (MR) PAS II II Mixing time (IR) AR/CBE IA IA/II AAPS/CPA Workshop, June 2829, 2021 17 Few Examples Manufacturing Site Change Changes US EU (old) EU (new) Different sites CBE30 (IR) PAS (MR) IA/IB IAIN/IB/II AAPS/CPA Workshop, June 2829, 2021 18 Few Examples Changes in Analytical Procedure/Specification Changes US EU (old) EU (new) Minor changes in testing method AR/CBE IA/IB IA Widen specification PAS II II Tighten specification AR IA IA AAPS/CPA Workshop, June 2829, 2021 19 Few Examples QbD Changes US EU (old) EU (new) Introduction of realtime release or parametric release in the manufacture of the finished product PAS II II Introduction of a new design space or extension of an approved design space PAS II II AAPS/CPA Workshop, June 2829, 2021 20 Thank You!
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