In updated guidance issued in May 2025, the European Medicines Agency (EMA) has clarified how third-party GMP audits of active pharmaceutical ingredient (API) manufacturers may be used in support of Qualified Person (QP) Declarations, specifically within Part C documentation.
The revision introduces a key change to responsibility and contractual structure for audit reliance. Under the clarified expectations, the Manufacturing and Import Authorisation Holder (MIAH) must now act as the Contract Giver for any audit used to support QP release decisions.
This means the auditing organisation must be directly contracted by the MIAH itself. Reliance on audits arranged through intermediaries, such as traders or other third parties, is no longer considered acceptable unless a direct contractual relationship exists between the MIAH and the auditing body.
In practical terms, this update tightens the traceability and accountability of GMP audits used in regulatory submissions. While third-party audits can still be utilised, their acceptability now depends on clear contractual alignment with the MIAH, reinforcing direct oversight rather than indirect sourcing arrangements.
The change is expected to prompt manufacturers and importers to reassess existing audit frameworks and ensure that contractual structures meet the updated EMA expectations for QP Declaration support.