INSIGHTS ON QUALITY CONTROL

• Leachables Method Development, Validation And Relevant ICH References

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements

  Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences

  Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

• Manufacturing Solutions

  3/4/2025

  Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.

• Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications

  6/19/2025

  Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.

• Automation-Assisted Washing Of Multicellular 3D Spheroids

  11/7/2025

  Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.

• Digitalizing Pharma Control Strategies: A Roadmap

  1/24/2025

  Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  6/18/2024

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.