PAT offers the possibility to measure critical quality attributes during the process without the need for additional release testing. This approach can be very attractive from a process efficiency perspective since release testing itself is automated, saving you significant handling, resources and process cycle time. For Continuous Processing, Real time Release is particularly interesting form a business case perspective. Challenging for Real time Release testing is the translation of PAT data to traditional release testing requirements. An important aspect to implement Real time Release effectively is a thorough GMP level validation in order to comply with existing regulations of health authorities.
Real time Release applications are typically intended for long term use and require an optimal design with respect to release criteria, user requirements and effectiveness. In addition, involved personnel has to be trained to manage the application adequately and independently.