The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
News|Articles|March 15, 2020
Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon
Author(s)J. Mark Wiggins, Joseph A. Albanese
This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
Advertisement
Advertisement
Related to this article
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
Karthik Iyer, Eli Lilly, detailed an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
2
Inluriyo-Verzenio Combo Doubles PFS, Adds Oral Complexity
3
Can AI Agents Satisfy CGMP Documentation Requirements?
4
CPHI Milan Brings Back Leadership Summit as Supply Chain and Manufacturing Pressures Ramp Up
5