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Q7 Implementation Working Group ICH Q7 Guideline: Good ...
database.ich.orgthe 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.
Q7 Implementation Working Group ICH Q7 …
www.ich.orgInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin des Mines 9, P.O. Box 195, 1211 Geneva 20, Switzerland