Topic: USP <1079> assigns “specific responsibility” to the manufacturer. In the case of contract manufacturing, who is regarded as the manufacturer?21 October 2014 Last edited: 21 October 2014 At 2:46pm
pharmamanufacturing Manufacturing Community Member 151 Posts
Re: USP <1079> assigns “specific responsibility” to the manufacturer. In the case of contract manufacturing, who is regarded as the manufacturer?21 October 2014 at 2:45pm Last edited: 21 October 2014 at 2:47pm
In the case of true contract manufacturing, the owner of the application has the final responsibility and accountability for the drug product. The contractor is accountable to the owner of the application. The applicant holder becomes the most responsible entity.
The entity with ultimate GMP responsibility is the entity that contracted out the manufacture, which is likely the
application holder or license holder for the product.
According to <1079>: “The holder of the drug product application, the drug product manufacturer (in the case of many OTCs, where there is no application) and the repackager bear primary responsibility and accountability…” In <1079> it seems the “manufacturer” is only mentioned for cases where there is no application.
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