Validation, Commissioning & Design Featured Articles

  1. Nasal Inhalation Delivery – An Introduction Guide 10/21/2024

    Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

  2. Harnessing Digitalization In Legacy Pharmaceutical Manufacturing 10/21/2024

    Digital technologies are revolutionizing cleaning validation in decades-old pharmaceutical facilities. Learn about innovative non-intrusive methods to overcome the digital divide in legacy equipment.

  3. A Data-Driven Approach to Cleaning Validation 10/21/2024

    Discover how Ongoing Process Verification, guided by PAT and digital integration, ensures consistent cleaning efficacy, reduces risks, and optimizes production efficiency in the pharmaceutical industry.

  4. Driving Continuous Improvement: Pushing Through The Barriers To Change 10/15/2024

    Discover how continuous improvement drives efficiency in pharmaceutical manufacturing. Learn strategies to harmonize processes and reduce environmental impact in this thoughtful exploration.

  5. Are These 5 Misconceptions Keeping You From Modernizing QC? 10/15/2024

    Explore common misconceptions that obstruct progress and why overcoming these barriers early provides a competitive edge when preparing for commercialization.

  6. Computer Systems Validation Pitfalls, Part 1: Methodology Violations 10/9/2024

    When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

  7. Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients 10/9/2024

    In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

  8. How Document Control Software Supports Digital Transformation Efforts 10/9/2024

    Embrace digital transformation in pharma manufacturing with advanced document control and quality management systems to enhance compliance, streamline processes, and accelerate time to market.

  9. Is Your Pharma QMS Equipped To Handle Risk? 10/9/2024

    In a rapidly evolving industry, see why adopting digital solutions is essential for achieving operational excellence and staying competitive.

  10. FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers 10/9/2024

    Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.