Outsourced Activities
EU GMP Chapter 7 — Outsourced Activities
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The EU GMP framework governing any GMP-related activity performed by a contract acceptor on behalf of a contract giver — manufacturing, packaging, testing, or ancillary services — requiring a written contract, defined responsibilities, and contract-giver oversight to ensure the contract acceptor’s facilities, personnel, and processes remain GMP-compliant.
EU GMP Part I Chapter 7 places clear obligations on both parties: the contract giver must assess the contract acceptor’s suitability before outsourcing and periodically thereafter, and remains ultimately responsible for the outsourced activities; the contract acceptor must not further subcontract without the contract giver’s prior written approval.
The chapter requires a written contract precisely defining the responsibilities of each party for quality matters, including batch certification, handling of deviations and OOS results, and access rights for the contract giver’s auditors and health-authority inspectors.
Outsourced activities extend beyond manufacturing to laboratory testing, storage and distribution, and even quality system activities such as pharmacovigilance case processing performed by a third party — the chapter’s principles apply wherever a GMP-relevant task is performed outside the marketing authorization holder’s own organization.
- —Applies to manufacturing, testing, packaging, and ancillary GMP-relevant services
- —Requires a written contract defining quality responsibilities of each party
- —Contract giver must qualify and periodically reassess the contract acceptor
- —Subcontracting requires the contract giver’s prior written approval
EU GMP Part I Chapter 7 (Outsourced Activities); ICH Q10
Frequently asked questions
What does Outsourced Activities stand for?
Outsourced Activities stands for EU GMP Chapter 7 — Outsourced Activities.
What is Outsourced Activities?
The EU GMP framework governing any GMP-related activity performed by a contract acceptor on behalf of a contract giver — manufacturing, packaging, testing, or ancillary services — requiring a written contract, defined responsibilities, and contract-giver oversight to ensure the contract acceptor’s facilities, personnel, and processes remain GMP-compliant.
Which regulations cover Outsourced Activities?
EU GMP Part I Chapter 7 (Outsourced Activities); ICH Q10