Responsibilities of the quality unit
Article 6
1. The quality unit shall be responsible for both quality assurance and quality control. 2. The responsibilities of the quality unit shall include, among others, the following elements: (a) release or rejection of active substances and intermediates thereof; (b) establishment of a system to release or reject raw materials, intermediates, packaging and labelling materials; (c) review of production batch and laboratory control records for critical process parameters before release of the active substance; (d) approval of: (i) specifications and master production instructions; (ii) procedures impacting the quality of active substances or intermediates thereof; (iii) intermediate and active substance contract manufacturers; (iv) changes potentially impacting the quality of the active substance or intermediates thereof; (e) review and approval of all appropriate quality-related documents; (f) ensuring that: (i) critical deviations are investigated and resolved; (ii) self-inspections and/or internal audits are performed; (iii) quality-related complaints are investigated and resolved; (iv) effective systems are used for maintaining and calibrating critical equipment; (v) materials are appropriately tested and the results are reported; (vi) stability data to support retest of active substances or intermediates is available, where appropriate; (g) performance of product quality reviews referred to in Article 8. 3. The responsibilities of the quality unit shall be documented in writing and shall not be delegated.