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GMP+ B2- TS 1.2- Purchase- Gatekeeper Protocol

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Posted 16 February 2022 - 02:15 PM

Can anyone advice under GMP+ B2 standard with reference to Ts1.2 Purchase- if a GMP+ certified company using external facility (non GMP+ certified) for production process means the certified company send the feed materials to non certified facility to process the feed materials and send back the processed feed materials to GMP+ company, does the external facility is considered as service provider? Means which gatekeeper protocols applies when non certified external facility is used if the processed feed materials are to be export to Europe countries later?

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