EU GMP Annex 17 - Real Time Release Testing and Parametric Release

What it says

Real time release testing allows evaluation and assurance of the quality of in-process and finished product based on process data, in place of or in combination with traditional end-product testing, requiring a validated process understanding sufficient to demonstrate the approach reliably predicts final product quality.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Real time release testing does not eliminate quality control - it replaces some traditional finished-product laboratory testing with in-process measurements and process parameters demonstrated, through validation, to reliably predict the same quality attributes.
• This approach depends on genuine process understanding developed during pharmaceutical development, connecting directly to the Quality by Design principles described in ICH Q8(R2).
• Parametric release specifically, most commonly applied to terminal sterilisation, substitutes validated process parameter verification for finished-product sterility testing, but only where the process parameters themselves have been rigorously validated to assure sterility.

What inspectors look for

• Whether the validation data underlying a real time release testing approach genuinely demonstrates the in-process measurements reliably predict the finished product quality attribute being replaced.
• For parametric release specifically, whether the validated sterilisation process parameters are consistently monitored and controlled within their validated ranges for every batch.
• Whether a real time release testing programme is periodically reviewed to confirm the underlying process understanding remains valid over time.

Related regulations