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Industry inspector team working, QC staff work checking machine operation for safety and hygiene | Image Credit: ©Quality Stock Arts – stock.adobe.com
New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

August 29th 2025

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

Ampoules vaccine from coronavirus with syringe 3d render illustration on white. | Image Credit: © mylisa - © mylisa - stock.adobe.com
FDA Approves Moderna’s Updated COVID-19 Vaccines Targeting LP.8.1 Variant

August 28th 2025

Blood sample tube contain with stem cell | Image Credit: © jarun011 - © jarun011 - stock.adobe.com
Zemcelpro Stem Cell Therapy Granted EC Conditional Marketing Authorization

August 28th 2025

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 28th 2025

Scientist wearing blue gloves pointing at charts and graphs on a paper document while analyzing medical research data using a tablet in a laboratory setting, with a microscope and beakers nearby | Image Credit: ©crizzystudio – stock.adobe.com
Specification Equivalence: A Practical Approach to Method and Acceptance Criteria Equivalence

August 28th 2025

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

Digitalization of QbD Risk Assessments; Image: photon_photo  - stock.adobe.com

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