Real-Time Release Testing (RTRT)

Definition

Real-Time Release Testing is an approach that uses in-process data, collected continuously during manufacturing, combined with validated process controls to release a batch without relying on additional traditional end-product testing. RTRT depends on a strong link between Critical Process Parameters, in-process controls, and Critical Quality Attributes.

Benefits

RTRT can significantly reduce the time between batch completion and product release, since the quality decision is supported by continuously collected process data rather than waiting for separate end-product testing to be completed after production finishes.

Use Case

A pharmaceutical manufacturer with a well-characterized process implements RTRT for a mature product, using validated in-process spectroscopic measurements captured throughout production. This is recorded automatically in the EBR to support batch release without a separate final dissolution test.

Frequently Asked Questions (FAQ)

Related Terms

• Critical Quality Attribute (CQA)
• In-Process Control (IPC)
• Batch Release