INSIGHTS ON QUALITY CONTROL

• Manufacturing Solutions

  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.

• Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

  Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.

• Strategic CMC Planning Through A Phase-Appropriate Quality Approach

  A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.

• Contamination Control Strategy With QRM Principles

  Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

• The Seamless Path To Market: End-To-End CDMOs As Your Strategic Ally Douglas CDMO

  5/14/2025

  Partner with an experienced end-to-end CDMO to streamline development, reduce risk, and accelerate your drug’s path to market in today’s complex and competitive pharmaceutical landscape.

• Mitigating Risks In Sterile Injectable Manufacturing: How CMOs Can Ensure Product Safety

  7/23/2025

  Sterile injectable manufacturing carries high risks. CMOs like Afton Scientific use rigorous quality systems, audits, and training to ensure patient safety, compliance, and product integrity.

• CMO Validation As A Service

  8/20/2024

  Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

• Vial Breakage During Lyophilization: Root Causes And Mitigation

  10/16/2024

  Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

• Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2

  12/27/2024

  Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.