Insights On Quality Assurance

  1. 5 Must-Haves For Electronic Batch Records In Life Sciences 6/17/2025

    Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.

  2. Overcoming Challenges In Ophthalmic Formulations Through Polymer Selection 8/27/2025

    The growing demand for ophthalmic drugs is driven by aging populations and increased screen time, which contributes to rising eye conditions. Explore innovative solutions in ophthalmic drug development.

  3. Strategies For QA Professionals In Life Sciences 7/14/2025

    Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

  4. Best Practices For Internal Quality Audits In Life Sciences 3/14/2025

    Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

  5. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  6. 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.

  7. Secure Your Sensitive Drug Substances 8/7/2025

    Explore the risks of freeze and thaw cycles on biological products and how an advanced plate freezing platform protects sensitive molecules with precision and ease.

  8. 4 Things To Consider In Pharmaceutical Labeling 12/11/2024

    Pharmaceutical labeling demands precision. Examine key considerations for ensuring accuracy and efficiency in your process, from robust control systems to diverse printing options.

  9. Correlating Stopper Height To Container Closure Integrity 11/21/2023

    Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

  10. Digital Transformation In Contract Manufacturing: A Leadership Perspective 5/13/2025

    Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.