Release Testing
The set of quality control tests performed on each batch of finished pharmaceutical product before it can be released for distribution and sale. Release testing confirms that the batch meets all specifications for identity, purity, potency, sterility, and other quality attributes.
Technical Context
Release testing represents the final quality gate before product distribution. The release specification set is defined in the regulatory filing (Module 3/CMC section of the CTD) and approved by regulatory authorities. Each test has: a validated analytical method (per ICH Q2), an acceptance criterion (specification limit), and a reference standard for comparison. Release testing must be completed for every batch before it is released for distribution — partial testing or skip-lot testing is generally not acceptable for parenteral products. Batch release authority rests with the Qualified Person (QP) in the EU or the quality unit head in the US. The QP/quality unit reviews: all batch production records, in-process control results, release test results, deviation investigations, and compliance with the marketing authorisation before authorising release. Any OOS result must be fully investigated before a release decision is made.