ICH Q13 — Continuous Manufacturing
Q13: continuous manufacturing of drug substances and products — control strategy, real-time release testing, and the analytical shift from batch pulls to in-line measurement.
Outline and talking points — the full write-up is still to come.
What this page covers
- What “continuous” changes: no discrete batch step, so residence time distribution, state of control, and material traceability become the control strategy.
- Process analytical technology (PAT) — NIR, Raman, in-line UV — moving the measurement onto the line.
- Real-time release testing (RTRT) — releasing product on process and in-line data instead of (or alongside) end-product testing.
- Batch definition, startup/shutdown, and diversion of non-conforming material.
- The analytical shift: from “take a sample to the lab” to “the line measures itself, and the analyst validates and monitors the model.”
Lecture prep — open items
- Pair with Q14 — PAT methods need the same lifecycle rigor.
- A real RTRT example (e.g. a CM tablet line) if one is publicly documented.
- Chemometric model maintenance — what happens when the feed material drifts.