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.
Tag
#regulation
11 articles tagged regulation.
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.
Hydrocarbons in industrial wastewater: continuous monitoring options and rules
Techniques for online hydrocarbon monitoring in industrial effluent, what each of them actually measures, and how revised EU rules and existing US methods frame the discharge limits.
Mid-year 2026: process analytics between earnings pressure and regulatory push
The first half of 2026 delivered mixed vendor earnings, an unusually dense regulatory calendar, and modest conference energy on the process-analytics floor. Here is what moved the needle.
ICH June 2026 mid-year update: E6(R3) Annex 2 final, Q1 and Q3E in review
At its Rio de Janeiro Assembly on 2-3 June 2026, ICH brought E6(R3) Annex 2 to Step 4, extending GCP to decentralised and registry-based trials. Q1 and Q3E remain in draft review.
Comparing FDA, EMA, and PMDA approaches to chemometric model lifecycle
FDA, EMA, and PMDA all build on ICH Q2(R2) and Q14, but their expectations for routine chemometric model upkeep, post-approval changes, and reference-method failures diverge in ways that shape submission strategy.
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.
Quality by Design (QbD): the PAT framework's parent
QbD is the broader regulatory philosophy that PAT serves. A primer on the ICH and FDA documents that built it, the vocabulary it introduced, and how process analytics fits inside it.
Continuous manufacturing in pharma: a status report through early 2026
Twenty years after the first FDA continuous manufacturing approval, the technology is no longer experimental - but adoption is uneven, and the bottlenecks are now organizational, not technical.
From PAT to ICH Q14: how regulators harmonized process analytics vocabulary
Twenty years of guidance documents - 2004 FDA PAT guidance, ICH Q8 through Q14, ASTM E2363 - turned a fragmented vocabulary into a working framework. A reading guide.
USP chapters 858 and 1858 at five years - where pharmaceutical Raman stands
USP chapters 858 (Raman Spectroscopy) and informational 1858 replaced chapter 1120 on 1 August 2020. Almost six years on, handheld identity testing is the workhorse application; compendial method adoption is uneven.