Biosimilar Regulatory solution center

1. Building Trust In AI For Computerized System Validation 9/4/2026

   Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

2. Controls For Retrieval-Augmented Generation In GxP 9/1/2026

   Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.

3. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

   When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

4. Chromatography Equipment Maintenance In An Era Of Acceleration 8/19/2026

   As chromatography systems become more sophisticated, maintenance directly influences uptime. Learn why coordinated maintenance strategies are essential for supporting complex analytical work.

5. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

   Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

6. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

   Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.

7. Transforming Computer System Validation In The Life Sciences Industry 7/10/2026

   Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

8. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program 7/7/2026

   In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

9. A Scalable Analytical Method For Quality-Driven AAV Characterization 7/1/2026

   AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.

10. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools 6/30/2026

    Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.