Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
News|Articles|October 17, 2025
How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging
Author(s)West Pharma
Manufacturers of sterile medicinal product. Entire supply chains entered a new era with the August 2023 EU GMP Annex 1 updates, all of which ultimately focus on enhanced public health protection. This article outlines the pharmaceutical manufacturers requirements to develop a comprehensive contamination control strategy that documents their assurance of sterile drug quality and patient safety.
Related to this article
Mahmood Majeed, ZS, explains why measurable AI outcomes in pharma supply chain and manufacturing jumped from 29% to 53%, and how GMP limits and GxP validation shape adoption.
BMS-Tempus, Roche-Zymeworks, and LGM-Sannova deals show what AI data, trispecifics, and nitrosamine testing mean for CMC, QA, and development teams.
Univar Solutions scientists developed a lidocaine cream built on starch, sorbitol, coconut oil, and beeswax that matched a commercial benchmark on viscosity, assay, and hydration.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Trending on Pharmaceutical Technology
1
Nitrosamine Problems and Industry Solutions: PharmTech Explained
2
OpenAI Bets on Accelerating Drug Development Timelines With Orchestra Bio
3
AAPS PharmSci 360 2026: E&L Standards Harmonization
4
Ask the Expert: Choosing Ingredient Suppliers
5