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.

For additional guidance towards current USP and EU GDP regulatory requirements, download the Strategic Cold Chain Management: USP, EC and Evolving Regulations eBook from Vaisala