INSIGHTS ON QUALITY CONTROL

• Effective Staffing Plans For GMP Drug Manufacturing Facilities

  In the manufacturing industry, the proper planning and staffing of GMP facilities and production lines are crucial for efficient operations and successful outcomes.

• 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.

• Seamlessly Integrating An E-WorkBook With A Customer's LIMS

  Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.

• Optimizing Contamination Control: Strategy Planning And Execution

  A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

• The Role Of Quality By Design In Pharmaceutical Tablet Development

  7/30/2024

  Quality by Design (QbD) ensures efficiency and high standards in pharmaceutical tablet development. Explore how this proactive approach transforms manufacturing processes and enhances product quality.

• Building A Connected Quality And Manufacturing Ecosystem In Life Sciences

  12/27/2024

  Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

• Achieving Licensing For A Healthcare Solution

  6/16/2025

  Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

• Understanding cGMPs For Phase 1 Investigational Drugs

  8/15/2025

  Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

• Building Control Strategies: It's Time To Go Digital

  1/24/2025

  Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.