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Eldin Rammell

I agree with Kathie in that these types of records are not usually managed within a TMF system. They can be requested during inspections – and the MHRA have explicitly stated that GMP batch records are part of the TMF – but are typically managed as part of GMP-regulated manufacturing records.

This is not a recommendation, but if you chose to file in the main TMF and therefore wanted to align them with an existing artifact rather than creating a new one, I suggest 06.02.03 might be the most appropriate….. based on the purpose/description of the artifact rather than the artifact name:
“Any certificate, license OR OTHER DOCUMENTATION that is required by a specific regulation to verify the quality, source, MANUFACTURE, ingredients or other aspect of investigational and/or control product.”

You could perhaps define sub-artifacts for production records / batch records under 06.02.03., though I would still prefer to see them managed outside the TMF system as GMP records.

Kind regards,