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发表于 2019-7-8 09:57:32
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Acceptable Total Carryover 可接受的残留总量
Oncethe ARL is determined, the maximum allowable carryover (MAC or MACO) can becalculated. MAC is the total amount of a target residue allowed in a batch ofthe next manufactured product. It is calculated by multiplying the ARL by theminimum batch size of the next product. MAC, which may be expressed in massunits for chemical residues (e.g., μg or mg or g), is expressed in thefollowing calculation:
一旦确定了ARL,可计算出最大允许残留量(MAC或MACO)。MAC是下一批产品中允许的目标残留物总量,可将ARL乘以下一产品的最小批量算出。对于化学残留物,MAC可以质量单位(如μg、mg或g)表示,如下式:
[Equation 5H] 公式5H
MAC = ARL × MBS
Where 其中:
MAC = the Maximum AllowableCarryover 最大允许残留量
ARL = the Acceptable ResidueLimit in the next product 下一产品中可接受残留水平
MBS = the Minimum Batch Size ofthe next product 下一产品的最小批量
Notethat the minimum batch size is typically expressed in mass units if ARL isexpressed as μg/g or in volume units if ARL is expressed as μg/mL. For APImanufacture, where both the cleaned product and the next manufactured productare APIs, Equation 5H is modified with MBS being the minimum batch sizeof the next drug active manufactured in the same equipment
注意:如果ARL以μg/g表示,则最小批量以质量为单位;如果ARL以μg/mL表示,则最小批量以体积为单位。对于原料药生产,已清洁产品和下一产品都是活性成分时,公式5H应予以调整,MBS应为同一设备中生产的下一活性成分的最小批量。
Becausethe MAC is the total amount allowed in the next manufactured product, it isalso the total amount allowed on shared equipment surfaces (that is, sharedbetween the cleaned product and the next manufactured product).
MAC是下一产品中总的残留允许量,它也是共用设备(已清洁产品和下一产品共用)表面允许的残留总量。 |
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