Validation, Commissioning & Design Featured Articles

31. Digitalizing Biopharma Manufacturing Step-By-Step: Part I 11/1/2023

    Digital transformation offers tangible advantages in terms of time, cost, and efficiency. Learn about a popular way to digitalize high-risk environments that can be achieved easily in biopharma manufacturing.

32. How Automation Can Help Fast Track Vaccines 11/1/2023

    The urgency of the coronavirus pandemic has demonstrated the need for expedited vaccine development. Discover how digital tools can help speed up the vaccine manufacturing process.

33. Remote Work Success Is Built On Pre-Site And Site Initiation Visits 10/31/2023

    The unique demands of remote work can require institutions to fundamentally change their organizational structure to empower the use of remote work tools and strategies.

34. FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities 10/25/2023

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

35. The Future Of Automation For Container Closure Integrity Testing 10/19/2023

    New regulatory guidance documents continue to tighten the narrative on what is expected of container closure integrity.

36. Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance 10/18/2023

    Ensuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.

37. Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses 10/18/2023

    Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.

38. The Digital Revolution: The Connected Lab Of The Future 10/12/2023

    The road to becoming a lab of the future can be challenging, with many obstacles along the way. Gain insight into the roles digital transformation and connectivity will play in the lab of the future.

39. Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations 10/12/2023

    Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.

40. Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations? 10/6/2023

    Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.