Understand ICH Q7 S3

Can other departments outside of the quality unit be held responsible for releasing raw materials and intermediates? Yes. The quality unit is responsible for establishing a system Yes. The quality unit is responsible for establishing a system to release or reject raw materials, intermediates, packaging, and labelling materials. This responsibility cannot be delegated [ICH Q7, 2.22(2)]. The system established by the quality unit may allow ‘other departments’ to release raw materials and intermediates (except intermediates that are for use outside the control of the manufacturer [ICH Q7, 2.22(1)]) as long as oversight and the overall responsibility of this system remains with the quality unit. Does ICH Q7 expect that sampling be performed by the quality unit? No. ICH Q7 does not prescribe specifically who should perform the sampling [ICH Q7, 2.22]. However, the quality unit has responsibility for reviewing and approving sampling plans [ICH Q7, 11.12] and procedures. Sampling should be performed by adequately trained personnel [ICH Q7, 3.10] and be appropriately documented as per [ICH Q7, 6.52]. What should be the frequency of a product quality review? A product quality review is generally expected annually. Review timeframes can be appropriately adjusted based upon manufacturing and campaign duration with adequate justification. Even if no manufacturing has occurred in the review period, the quality review should be conducted as per section [ICH Q7, 2.50] and include stability, returns, complaints, and recalls. For example, a product quality review may encompass more or less than 12 months depending upon product campaign duration [ICH Q7, 2.50; ICH Q10, 2.6].