The European Commission has released for comment a revision to Chapter 7 of the EU GMP Guide on outsourced activities that expands the scope of coverage and incorporates quality system and risk management principles from ICH Q9&10.
Chapter 7, formerly “Contract Manufacture and Analysis,” has been re-titled “Outsourced Activities” to reflect an expansion of its scope to cover all GMP-related outsourced activities. Comments are due by February 28, 2011.
The EU effort to update its GMPs on outsourcing parallels the heightened attention that the area is getting from FDA.
FDA’s compliance and field offices have made clear both from the podium and in inspections and follow-up warning letters that contractor/sponsor relationships are high on the agency’s radar screen (IPQ “In the News” June 18, October 6, October 16, and October 28).
The revised EU GMP chapter is divided into the following sections: ● Table of Contents ● Principle ● General ● the Contract Giver ● the Contract Acceptor, and ● the Contract.
The existing chapter does not include a table of contents. While the five sections in the existing chapter have the same titles, there are additional expectations for the outsourcing relationship spelled out in the last three sections of the new draft.