Secondary Manufacturing Site on DoC

D

DH1981

Starting to get Involved
#1
#1
Could anyone comment on secondary manufacturing sites called out on DoCs?

If the product is only being manufactured at one site (which in this case is the Legal Manufacturer site), can the secondary site be mentioned even if commencement of manufacture has not been concluded at this stage?

The thought process is to save time in the future, should/when manufacturing ever start at the second site.

Thanks
 
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chris1price

chris1price

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#2
#2
If you have not commenced manufacture at the second site, can you show that all the validation and risk assessments have been performed for that site and for product manufactured there? If not, I don't think you can declare they conform.
 
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