Validation, Commissioning & Design Featured Articles

  1. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

  2. Why The Latest Technology Helps Navigate Evolving Regulator Expectations 11/27/2024

    By embracing data-driven insights, companies can confidently navigate complexities, reduce risks, and deliver trusted products to global markets.

  3. The Importance Of Operator Equipment Training 11/18/2024

    Learn why a strong commitment to operator training is essential to prevent production issues, ensure product quality, and safeguard patient safety.

  4. A Guide To QbD For Small Molecule Drug Product Manufacturing Excellence 11/13/2024

    Leveraging the quality by design (QbD) approach to achieve manufacturing excellence is game-changing. This article shares QbD principles, benefits, and successful case studies.

  5. Three Vital Steps To QMS Implementation 11/7/2024

    When selecting a QMS, it may feel like the most challenging step is making the purchase. This is not necessarily the case. Read more about the challenges of implementing an effective QMS.

  6. Biopharmaceutical Manufacturing Conference: Embracing Technology And Innovation 11/6/2024

    Industry leaders gathered at the PDA Ireland Chapter event to discuss how innovation and technology are transforming biopharmaceutical manufacturing, addressing challenges, and driving efficiency.

  7. Best Practices In The Design Of A Pharmaceutical Manufacturing Facility 11/6/2024

    A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.

  8. Understanding The FDA Recall Risks And Solutions For Life Sciences Manufacturers 11/5/2024

    Investigate the factors contributing to FDA recalls, the effects on both consumers and businesses, and how integrated digital solutions can play a crucial role in preventing such incidents.

  9. Top 3 Things To Consider When Designing A Risk-Based Cleaning Validation Process 10/23/2024

    Learn how implementing a systematic approach to cleaning validation can significantly enhance compliance and improve your audit readiness.

  10. Navigating The Paradigm Shift: Ensuring Efficacy In Risk-Based Cleaning Validation 10/23/2024

    Unearth how adopting a risk-based approach to cleaning validation can enhance product quality, safety, and regulatory compliance in pharmaceutical manufacturing.