Articles tagged with “quality-by-design”

ICH Q2(R2) Guide: Analytical Method Validation Explained

Understand analytical method validation with this deep dive into ICH Q2(R2). Explore validation parameters, documentation, and the new QbD lifecycle approach wi

50 min read

1/8/2026

analytical method validation ich q2(r2)ich q14 validation parameters pharmaceutical quality quality by design gmp regulatory compliance

PAT Sensors for Real-Time Reaction Monitoring in Pharma

Learn how Process Analytical Technology (PAT) uses sensors like NIR & Raman for real-time reaction monitoring in pharmaceutical manufacturing to improve quality

35 min read

1/7/2026

process analytical technology pharmaceutical manufacturing real-time monitoring in-line sensors nir spectroscopy raman spectroscopy quality by design chemometrics

Quality by Design (QbD) & PAT in Pharma Manufacturing

Learn how Quality by Design (QbD) and IT systems are shifting pharma from end-product testing to real-time quality assurance with PAT and data analytics.

30 min read

1/7/2026

quality by design process analytical technology pharma 4.0 pharmaceutical manufacturing continuous manufacturing quality assurance ich q8 gmp

ICH Q8 Explained: A Guide to Pharmaceutical Development & QbD

Learn about the ICH Q8 guideline for pharmaceutical development. This in-depth guide explains Quality by Design (QbD), QTPP, CQAs, and the design space concept.

40 min read

11/15/2025

ich q8 quality by design qbd pharmaceutical development design space qtpp critical quality attributes ich guidelines control strategy ctd module 3.2.p.2

ICH E6(R3) Explained: A Guide to the 2025 GCP Update

An in-depth analysis of the ICH E6(R3) Good Clinical Practice guidelines for 2025. Explore key changes in Quality by Design, data governance, and decentralized

35 min read

10/13/2025

ich e6(r3)good clinical practice gcp guidelines clinical trials quality by design decentralized trials data governance regulatory compliance