Insights On Quality Assurance

  1. GMP Compliance For Pharmaceuticals And Medical Devices 3/14/2025

    Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.

  2. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  3. Drive Innovation With Validation 4.0 7/1/2025

    Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.

  4. In Silico Approaches Towards Automated Biomanufacturing 11/6/2023

    As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.

  5. 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.

  6. Cambrex Scientist Spotlight: Shawn Conway 1/29/2025

    Shawn Conway, Senior Director of Operations in High Point, NC, leads a dynamic team of engineers and chemists at Cambrex, focused on supporting clients throughout the entire product life cycle.

  7. AI Implementation To Enhance Quality 2/11/2025

    Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

  8. The Shift From CSV To CSA 7/9/2024

    Explore current industry challenges, the urgent need to implement Computer System Assurance (CSA), and an approach to aid the pharmaceutical sector in understanding and embracing this essential shift.

  9. 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.

  10. Supplier Quality And The True Cost Of Recalls 2/20/2025

    Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.