原料药GMP执行培训讲解课件.ppt

API中的杂质 Solvents 溶剂 Water 水 Metals 金属 Salts 盐 Organics 有机物 Byproduct 副产物 Degradants 降解物 Reactants, Intermediates, Catalysts, Ligands, Process Aids 反应物,中间体,催化剂,配价物,添加剂 An impurity is any component present in the intermediate or API that is not the desired entity 杂质是出现在API或中间体中的任何不被期望产生的物质。 * API中的杂质 Impurity profile (identified and unidentified) for API should be established 应建立杂质概况(已鉴定的和未鉴定的) identity (or some qualitative analytical designation) 鉴定(或定性分析) range observed 监测范围 classification (inorganic, organic, solvent, etc) 分类(有机,无机,溶剂等) Impurity profile is for typical batch produced by specific controlled production process 杂质概况乃是针对由特定控制过程所生产的批次 * API中的杂质 Impurity profile for API API的杂质概况 compared at appropriate intervals vs profile in regulatory submission or historical data 定期与注册的杂质概况或历史数据对比。 to detect changes resulting from modifications in raw materials, equipment operating parameters, production process 监测由原材料,设备操作参数,生产工艺的改变所带来的变化。 * Importance of Impurities to API ProductionAPI生产中杂质的重要性 Generally more potential residues or contaminants in API production than dosage form production一般而言,API生产比制剂生产有更多潜在残留和污染的可能。 Presence of precursors and by-products in APIs may be more serious than an excipient residue present in dosage forms API中的前体和副产品比制剂中的赋形剂残留更为严重。 * 历史教训 任意变更生产工艺产生新的杂质，产生重大的安全问题。 * Presence of Impurities in APIs