Quality and Regulations 2026 eBook

Modern digital illustration depicting supply chain challenges in pharmaceutical and medical logistics with interconnected icons | Image Credit: ©KHAN VECTOR CO. -stock.adobe.com

Digital Standards Aim to Modernize Quality Assurance Without Compromising Confidence

July 30th 2026

As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.

Adeno-associated virus. AAV virus genome. Adenoviral pneumonia, arthritis, bronchitis, hepatitis, cystitis. Adenovirus as vectors for gene therapy. Genetic material transmission to cell. Biotech 3D | Image Source: ©Corona Borealis -stock.adobe.com

Viral Safety 2.0: Plant-Ready Actions for ICH Q5A(R2) Compliance

ByJohn Muganga

July 30th 2026

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

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What FDA's AI Warning Letter Tells Us About GMP Accountability

ByGourav Pandey,Svyatoslav Borshchenko

July 30th 2026

An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.

Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Dr. Jeffrey C. Mocny and Cellares’ Anna McMahon

ByFeliza Mirasol,Jeffrey C. Mocny,Anna McMahon

May 12th 2026

Abzena’s Dr. Jeffrey C. Mocny and Cellares’ Anna McMahon discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.