Validation, Commissioning & Design Featured Articles

31. Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety 7/23/2025

    Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.

32. Contamination Control Strategies For Gene Therapy Manufacturing 7/23/2025

    Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

33. FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline 7/17/2025

    The FDA changed expectations for nitrosamine drug substance-related impurities reporting, accepting progress reports in lieu of full compliance. Here's what it means.

34. Aiming For Success In Early mAb Process Development And Beyond 7/15/2025

    Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

35. The Role Of CDMOs In Supporting Generic Drug Development 7/15/2025

    Bringing complex generics to market requires deep expertise. Learn how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end development and manufacturing support.

36. Building A High-Fidelity Manual Baseline For Tomorrow's Automated Inspection 7/14/2025

    Future-proof your pharma manufacturing. Discover why manual visual inspection remains foundational and how advanced software can build a high-fidelity baseline for automation success.

37. 6 Things To Consider During Visual Inspection Operations 7/14/2025

    Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.

38. How Software-Enabled Manual Visual Inspection Can Boost Your ROI 7/14/2025

    Unlock hidden cost savings in pharma manufacturing. Learn how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.

39. From Setup To Sign-Off: Managing Simultaneous Reviews In Veeva Vault 7/9/2025

    Collaborate on complex documents with ease with an integrative platform that empowers high-volume teams to streamline workflows, boost compliance, and accelerate reviews within a secure environment.

40. Advancing Sterile Manufacturing: A Strategic Imperative For Modern Pharmaceutical Production 7/9/2025

    Ensuring sterile drug production is vital for patient health and a key regulatory focus. Discover core principles and emerging trends in sterile manufacturing.