EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control

Changes to the EU regulations that govern technical agreements, outsourced activities, active pharmaceutical ingredient (API) supply chains, and the storage and transit of medicines are in progress and expected to be released soon for public consultation.

The changes to the EU regulations “will significantly affect anybody who wants to supply to Europe,” MHRA GMP Inspector Rachel Carmichael emphasized at a Global Outsourcing Conference at Xavier University on June 14.

The EU effort to strengthen its supply chain rules parallels a similar move underway in the US, which was also discussed at the Xavier conference (see “In the News” June 16 companion story).

Over the past few years, MHRA and EU inspectors have noted deficiencies in technical agreements that govern how firms outsourcing activities and their contractors performing the tasks work together.  Deficiencies cited include not having an agreement or a requirement for one in place, documents not routinely reviewed, and lack of detail regarding technical and GMP responsibilities.

“Our general stance is if you do not have a signed technical agreement in place you ought not to be doing any work,” Carmichael emphasized, noting that “if you have not defined what your expectations are you cannot really be that surprised if they do not deliver on them.”  The fact that a company has outsourced activities to a professional organization does not mean that it fully understands the details of what is expected, she noted.

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