EU GMP Chapter 7 - Outsourced Activities

What it says

Any GMP activity outsourced to a contract acceptor must be defined in a written agreement between the contract giver and contract acceptor, clearly establishing the responsibilities of each party, with the contract giver retaining ultimate responsibility for the quality of outsourced activities and the right to audit the contract acceptor's facilities.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Outsourcing an activity does not transfer accountability for that activity's quality outcome - the contract giver, the company relying on the outsourced work, remains ultimately responsible regardless of what the contract itself says about operational responsibilities.
• The written agreement must be specific enough to actually define who does what, avoiding ambiguity about which party is responsible for which quality-relevant activity, since ambiguous contracts create exactly the kind of oversight gap this chapter exists to prevent.
• Audit rights over the contract acceptor's facilities are an explicit, retained right of the contract giver, not something requiring separate negotiation each time oversight is needed.

What inspectors look for

• Whether written agreements between contract giver and contract acceptor clearly and specifically define quality-relevant responsibilities for each party.
• Whether the contract giver genuinely exercises oversight of the contract acceptor, through audits and ongoing quality monitoring, rather than treating outsourcing as removing the need for active oversight.
• Whether contract acceptor performance issues are fed into the contract giver's own quality system, including complaint and CAPA data, rather than being managed entirely outside that system.

Related regulations