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What’s the minimum amount of information required for the labels on containers of starting materials when they are received prior to API manufacturing?

834 viewsOctober 10, 2022DrugsPharmaceutical
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Sam Smith11.38K February 9, 2021 0 Comments

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Blogolu28.38K Posted February 9, 2021 0 Comments

Section 7.2, “Upon receipt and before acceptance, each container or grouping of containers of
material should be examined visually for correct labeling, including correlation between the name
used by the supplier and the in-house name, if they are different.” That’s essentially all that has to
be done. That’s the only reference in here to material that has to be on the label for incoming
starting materials. This is an answer that pertains to what is required with regard to GMPs.
Just to clarify one thing, Section 6 does not describe what needs to be on the labels of materials
that are coming into you. It does describe what kind of records you need to keep about those
materials.

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