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|December 20, 2023
21 CFR Part 11 Compliance Checklist
Author(s)Sartorius
The Cubis®️ II balance, equipped with a pharma package, provides technical features for regulatory compliance in pharmaceutical quality control. Complete compliance requires extra procedural controls and data storage systems. Our checklist highlights key regulatory details and shows how Cubis®️ II facilitates full pharma compliance.
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
AAPS PharmSci 360 2026: System Suitability Standards in E&L Testing
5