AI-Enhanced Robotics in Pharma Manufacturing Signals Major Efficiency, Margin Expansion Opportunities

Editorial Coverage: Pharmaceutical manufacturing is undergoing a structural shift as regulators demand higher standards for contamination control, data integrity and operational traceability. The ...
PharmTech

Is Your Annex 1 Strategy a Static Document or a Dynamic Defense?

The 2023 revision of Annex 1 of the European Union’s good manufacturing practice (GMP) guidelines 1 represents a fundamental shift in expectations for sterile manufacturing. Reg ...
Contract Pharma

Isolators vs. Cleanrooms for Sterility Testing: Considerations for Regulatory and Operational Efficiency

In this Pharma Matters Q&A, Amina Rahmoune of Nelson Labs evaluates and compares sterility testing in cleanrooms and isolators.
Contract Pharma

GMP Annex 1 Implementation: How Ready-To-Use Vials and Cartridges Can Meet New Regulation Requirements Efficiently

Learn how ready-to-use vials and cartridges can aid in GMP Annex 1 Implementation and streamline compliance with EU ...
Labroots

The Impact of Annex 1 and Your Contamination Control Strategy

Bio: Don Singer is a Fellow in the American Society for Quality and formerly a GSK Senior Fellow. Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since ...
WGN-TV

Klaritex Inc. Releases New Report on 10 Cleanroom Trends Reshaping North America and Their Impact on Eye Protection

President & CEO Atif Sarfraz highlights key regulatory, operational, and human-factors shifts that are redefining cleanroom goggles in North America Cleanrooms are experiencing fundamental shifts in ...