CRED Getting the CMC Dossier Right 2024

28/08/2024

Parametric/Real Time Release (RTR) testing

• Operational alternative to routine release testing

• Batch release is based on monitoring specific processing parameters • Sterility testing for terminally sterilized products is one example • Temperature, pressure and time of the sterilization cycle are more accurately controlled, measured and reliable parameters demonstrated to give assurance the product meets specification

• Guideline on Real Time Release testing in Oct 2012 (EMA/CHMP/QWP/811210/2009-Rev1)

• Biological/biotechnological products RTR is an option if it can be demonstrated that acceptable levels would be maintained in the final product, if tested.

• When parametric release is performed, the parameter should be included in the specifications together with a reference to the associated test procedure.

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Alternative Procedures and Evolving Technologies

• Alternative procedures can be used if demonstrated to be comparable or superior to the official procedure

• New analytical technologies and modifications are continually being developed and should be used when considered to offer additional assurance of quality or are otherwise justified.

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