How ICH Q9(R1) Applies to Chemometric Models in Pharmaceutical PAT
Quality risk management under ICH Q9(R1) reshapes how pharmaceutical manufacturers classify, validate, and maintain chemometric models embedded in process analytical technology.
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16 articles tagged pat.
EMA post-approval CMC changes for chemometric models: how variations are classified
Each update to an approved chemometric procedure in the EU is a regulatory event. Commission Regulation No 1234/2008 and ICH Q14 determine which variation type applies and whether prior approval is needed.
IFPAC 2026: continuous manufacturing and AI take centre stage at the 40th annual forum
The 40th IFPAC Annual Meeting in North Bethesda centred its March 2026 program on AI integration, continuous manufacturing, and tightening regulatory expectations for advanced pharma production.
Continuous crystallisation PAT: measurement choices and endpoint definitions
What to measure inline when crystallisation runs continuously, which PAT tools fit which regime, and how endpoint stops being a moment and becomes a window.
NIR vs process Raman for fertiliser and phosphoric acid streams: how to choose
Fertiliser and phosphoric acid streams stress process NIR and Raman in different ways. Here is how to choose between them, one analyte at a time, before writing the URS.
ICH Q13 at three years: continuous manufacturing uptake in 2026
Three years after ICH Q13 came into force, 17 continuous-manufacturing drug approvals sit on the FDA's ledger and 72 CM technologies have joined the Emerging Technology Program - but adoption remains narrow.
EuroPACT 2026 preview - Lyon in May, three pillars, four plenaries
The 7th European Conference on Process Analytics and Control Technology runs 4-7 May 2026 at the Cite Centre de Congres Lyon. Three scientific pillars, four confirmed plenaries, and a special focus on integrated AI.
Detecting and acting on chemometric model drift in production
A production chemometric model is a living asset. Detection catches drift before it silently biases release decisions; the response ladder tells the plant what to do next.
Bayesian chemometrics for process monitoring: what the 2025-2026 papers say
Recent papers push Bayesian uncertainty into the same workflows that PLS has owned for two decades. Where the ideas stick, and where they still stumble in production.
Process mass spectrometry: where MS fits in PAT today
Quadrupole and membrane-inlet mass spectrometers sit between gas chromatography and inline spectroscopy in the PAT toolkit. The placement and the limits of the technique are settled, even if vendor marketing is loose.
Bioprocess Raman analyzers: a focused 2026 review
Six vendors that matter for bioreactor monitoring - what each one is good at, what they are not, and the methodology we used to scope the field down from the full process Raman market.
Calibration transfer between instruments: a working protocol
A partial least squares model rarely survives the move to a second instrument unchanged. A working protocol covers transfer set design, the standardisation method, and the acceptance criteria.
Peer-reviewed PAT validation work, late 2025 to spring 2026
Six recent peer-reviewed PAT papers worth a read: lean chemometrics for spectroscopic models, simpler bioprocess Raman regressions, at-line terahertz for crystallinity, and PAT-with-machine-learning past the bioreactor.
Inline, online, atline, offline: the working vocabulary for sample placement
ASTM E2363 fixes four terms that engineers and scientists frequently misuse. A short reference for getting placement vocabulary right when scoping a process analytics project.
EMA Q&A on 3D-printed oral doses endorses inline NIR and Raman
EMA's March 2026 Q&A on 3D-printed solid oral doses accepts inline NIR and Raman spectroscopy for unit-level rejection, anchoring personalised micro-batches in the QbD and RTRT framework.
Time-gated Raman in 2025-2026: recent papers on fluorescent matrices
Recent peer-reviewed work on time-gated Raman - 512-pixel SPAD line arrays, Fourier-transform variants, and time-resolved use beyond fluorescence rejection - and what process-analytics teams can take from it.