USP general chapters in 2026: what is still open for comment
The comment window on Pharmacopeial Forum 52(4) closes on 30 September. Here is what USP has out for consultation this year that matters to analytical and process-analytics teams.
Evonik's Q2 2026 adjusted EBITDA surged 24% to €630 million as crosslinkers, high-performance polymers, and amino acids defied macro headwinds - a signal worth parsing for the process analytics sector.
Shimadzu posted a sixth consecutive record quarter with Q1 FY2027 net sales of ¥130.6 billion, then raised its full-year guidance to ¥620 billion as the Tescan electron-microscope acquisition nears consolidation.
Roche's Diagnostics division posted CHF 6.7 billion in H1 2026, up 3% at constant exchange rates and 6% excluding China, where healthcare pricing reform continues to weigh on the segment.
Quality risk management under ICH Q9(R1) reshapes how pharmaceutical manufacturers classify, validate, and maintain chemometric models embedded in process analytical technology.
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.
FY2026 FDA warning letters keep citing the same analytical procedure gaps: HPLC audit trails, OOS handling, method validation. What Ava, Intas, Huons and Sanofi Waterford suggest for QC labs.
Papers published over the past year test whether plants can train a shared spectroscopic model without pooling spectra. The method works on paper; the instrument physics is the harder part.
Terahertz spectroscopy reached tablet compression lines, battery electrode inspectors, and airborne gas monitors in 2025-2026 - a survey of the papers that moved the technique toward routine industrial use.
A survey of 2026 papers on deep learning for Raman peak resolution: self-supervised transformers, learned baselines, simulation-driven denoising, and benchmarks that keep 1D CNNs in the game.
A hybrid laser-paramagnetic gas analyzer and a refreshed edge AI platform mark Emerson's two most significant process analytics moves in the first three quarters of fiscal 2026.
Anton Paar extended its inline sensor portfolio in 2025-2026 with compact L-Rix refractometers and a fourth-generation Cobrix beverage analyzer family, and added subsidiaries in three new markets.
Yokogawa's H1 2026 process-analyzer moves were not new hardware. A February deal with CMC Solutions makes Yokogawa the global distributor of PEMS software, extending emissions monitoring beyond hardware CEMS.
Cosmetics plants compound rather than synthesise, so the measurement targets are composition and homogeneity. Raman reaches both - where fluorescence and matrix overlap allow it.
CQA, CPP and CMA get used interchangeably in PAT documents. Two of the three are formally defined by ICH and the third is not. A working guide to what each term means and where the lines fall.
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.
Wet-process acid, granulation loops and liquid-fertiliser blending pull in five different analyser families. Which vendors are credible in each, how we screened them, and where the shortlist narrows.
Six techniques, roughly thirty vendors. Where inline Raman, NIR, mid-IR, dielectric, ultrasonic, and inline rheology each fit resin and coatings production - and how we screened the field.
A composite of commissioning patterns from fertiliser plants. The spectrometer is rarely the problem. The sample point, the dust zone file, the grade campaign, and the reference lab are.
A composite of patterns from inline Raman commissioning projects on new-build lines. The physics rarely delays the go-live; the sample point, the ATEX file, and the calibration set do.
A chemometric model changes more often than the instrument it runs on. Change control is the quality-system machinery that decides which of those updates needs an assessment, an approval, and a filing.
Continuous ethoxylation loop reactors compress the useful measurement window and change how an inline analyser is specified. A working URS starts with technique, then probe, then integration.