MAJOR CHANGES (MAJ)
MAJ1 – Change/addition of the manufacturer of a starting material or intermediate, when the proposed manufacturer uses a substantially different route of synthesis or manufacturing conditions, which are likely to change the qualitative and/or quantitative impurity profile (eg. new reagents, solvents, materials are introduced in the synthesis)
MAJ2 - Change in the manufacturing process of the final substance that regards the sterilization step(s), including changes in batch size of a sterile substance
MAJ3 - Substantial change to the manufacturing process/addition of an alt-ernative manufacturing process for a starting material, intermediate or final substance likely to change the qualitative and/or quantitative impurity profile (eg. new reagents, solvents, materials are introduced in the synthesis)
MAJ4 - Changes in the manufacturing process of a herbal substance related to geographical source or production
MAJ5 - Widening or deletion of approved in-process test limits, which may have a significant effect on the overall quality of the final substance
MAJ6 – Widening of the approved specifications limits for the final substance
MAJ7- Widening of the approved specifications limits for starting materials/ intermediates, which may have a significant effect on the overall quality of the final substance
MAJ8 - Deletion of a specification parameter which may have a significant effect on the overall
quality of the final substance
MAJ9 - Change in the composition of immediate packaging for a sterile substance
MAJ10 - Introduction of a new design space or extension of an approved design space or of a post approval change management protocol related to the final substance
重大变更 (MAJ)
MAJ1 –变更/增加起始物料或中间体的生产厂家,新厂家使用的合成工艺或生产条件与原厂家的有很大不同,可能会改变产品定性和/或定量的杂质情况(如在合成工艺中引入新试剂、新溶剂、新物料)
MAJ2 –产品灭菌步骤的生产工艺变更,包括无菌制品的批量变更
MAJ3 – 起始物料、中间体或产品的生产工艺变化较大/增加一个替代的生产工艺,可能会改变定性和/或定量的杂质情况(如在合成工艺中引入新试剂、新溶剂、新物料)
MAJ4 - 与地理产地或制造相关的草药的生产工艺变更
MAJ5 -放宽或删除中控限度,可能对产品总体质量产生重大影响
MAJ6 –放宽产品质量标准的限度
MAJ7-放宽起始物料/中间体的质量标准的限度,可能对产品总体质量产生重大影响
MAJ8 – 删除质量标准参数,可能对产品总体质量产生重大影响
MAJ9 - 无菌产品内包材成分改变
MAJ10 – 引入新的设计空间或扩大已批准设计空间的范围,或引入与产品相关的批准后的变更管理计划 [搞不懂这句话具体是指什么?]
TSE changes
MAJ11 – Change/addition of a source country or tissues for TSE risk material
MAJ12 - Change/addition of a manufacturer of a starting material or intermediate
MAJ13 – Change/addition of a manufacturing site where other TSE materials than the substance are processed
MAJ14 - Substantial changes in the manufacturing process that are likely to affect the TSE risk
TSE 变更
MAJ11 –变更/增加TSE风险物质的来源国或组织
MAJ12 -变更/增加起始物料或中间体生产厂家
MAJ13 –变更/增加生产厂地,(此生产厂地)也生产其他TSE风险物质
MAJ14 -可能会影响TSE风险的生产工艺重大变更