door Gregory Sivo | mei 31, 2026 | General
By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read GMP audit preparation has a way of turning into a last-minute scramble. This article explains why that happens, what the scramble reveals about the underlying quality system, and how... door Gregory Sivo | mei 25, 2026 | General
By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read Learn what EU GMP and ICH Q10 require from a change control system, why change control programmes fail in practice, and what a compliant, inspection-ready process looks like from the inside. One... door Gregory Sivo | mei 17, 2026 | Niet gecategoriseerd
Learn what GMP regulations require from management reviews, why they so often fail in practice, and what a compliant, inspection-ready review record looks like. One of the first questions we ask when we arrive at a regulated site is simple: when was your last... door Gregory Sivo | mei 11, 2026 | Niet gecategoriseerd
By a GMP Compliance Specialist | Updated May 2026 | 12-minute read Regulatory agencies don’t stand still — and neither should your quality system. Whether you’re operating under EU GMP, FDA 21 CFR Part 211, or ICH Q10, one expectation runs through every... door Gregory Sivo | mei 4, 2026 | General
Waarom dataintegriteit de dominante GMP-bevinding van 2026 zal zijn Als u zich voorbereidt op een inspectie in 2026, is er één gebied waarop de voorbereiding bovenaardig robuust moet zijn: dataintegriteit. Tussen 2016 en 2023 heeft de FDA 1.766 waarschuwingsbrieven uitgedeeld...