Latest News

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s
New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

August 28th 2025

The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.

A hand is placing the final wooden block with a green certificate checkmark, symbolizing achievement, quality assurance and completion, against a plain pastel blue background. | Image credit: TimmyTimTim – stock.adobe.com
Continued Process Verification Is Critical in Pharmaceutical Manufacturing

August 27th 2025

Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence
Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

August 27th 2025

Image by Drew Kazdin/MJH Life Sciences using AI
The Evolving Science Behind Formulation Development

August 26th 2025

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com
Johnson & Johnson Invests $2 Billion into North Carolina Facility

August 21st 2025

Review of SUT Adoption in Biopharma Manufacturing

The evolution of therapeutic modalities drives the adoption of single-use technologies.

Review of SUT Adoption in Biopharma Manufacturing; Image: mailsonpignata - stock.adobe.com

More News