While the quality unit has responsibility for the release of the API, which includes oversight of the testing and results, ICH Q7 does not prescribe specifically who performs testing. ‘quality control’ in the ICH Q7 Glossary [ICH Q7, Section 20] refers to the activities, not the organisational structure. For examples of quality responsibility related to testing and release, refer to [ICH Q7, Sections 2.13, 2.22, and 11.12]. Appropriate laboratory controls should be followed [ICH Q7, Sections 11.10, 16.10] regardless of who performs the testing.
