Dual Lot Manufacturing requirements for Clinical Customers

D

dmac21

I am new to this forum, but am hoping I might get some feedback on an issue I am struggling with: We are having an internal debate on what constitutes effective dual lot manufacturing: one side of the debate claims that dual lots from the bulk level up is sufficient, while the other insists that dual lots require that raw materials also be unique. How do you define 'dual lot' and what do your customers require?
 

somashekar

Leader
Admin
I am new to this forum, but am hoping I might get some feedback on an issue I am struggling with: We are having an internal debate on what constitutes effective dual lot manufacturing: one side of the debate claims that dual lots from the bulk level up is sufficient, while the other insists that dual lots require that raw materials also be unique. How do you define 'dual lot' and what do your customers require?
dual lots from the bulk level up is sufficient,
Seems sensible and traceable
dual lots require that raw materials also be unique.
Perhaps when customer specific or an internal call
 
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