INSIGHTS ON QUALITY ASSURANCE

• The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns

  In biopharmaceutical manufacturing, seemingly minor components like seals can pose significant risks to product purity. Overlooking them can lead to contamination and costly delays.

• 5 Key Elements Of Quality By Design In Pharma

  Learn about the advantages of embedding quality throughout design and manufacturing, explore five practical elements of QbD in pharmaceuticals, and discover how a QMS can support QbD.

• Quality Without Compromise: GMP Annex 1 For Sterile Manufacturing

  Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

• A Roadmap For PAT Implementation

  Through its real-time monitoring and control, PAT supports a proactive approach to quality management, reducing variability and improving the robustness of pharmaceutical production processes.

• Why Biopharma Breakthroughs Aren't Moving The Market

  10/20/2025

  Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

• Cell Culture Media Mixing In A Benchtop Single-Use Mixer

  11/13/2025

  Explore how efficient powder-liquid mixing and sterile filtration preserve media integrity and support reproducibility in biopharmaceutical workflows, with promising scalability for larger-volume applications.

• Navigating Digital Transformation For Pharmaceutical CDMOs

  10/31/2025

  Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.

• 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.

• Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market

  2/2/2024

  Requirements to maintain a GxP environment mean researchers must conduct software validation on any updated software so it continues to meet users’ needs.