document part CTA Section 3.2.S.2.4 Controls of Critical Steps and Intermediates The document part of the common technical document that specifies tests and acceptance criteria (with justification including experimental data) performed at critical steps identified in 3.2.S.2.2 of the manufacturing process to ensure that the process is controlled. Information on the quality and control of intermediates isolated during the process is also provided. Reference ICH guidances Q6A and Q6B. [PROCO]