Insights On Quality Control

  1. Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance 6/6/2024

    Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

  2. 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.

  3. 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.

  4. Consolidating The Supply Chain For mRNA 2/12/2024

    Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.

  5. Development To Large-Scale cGMP Production 7/25/2024

    For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

  6. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  7. Detecting Drug-Excipient Incompatibility In Pharmaceuticals 5/5/2023

    Here, we focus on how the apparent melting approach can provide a rapid screening protocol for the detection and analysis of drug-excipient incompatibility in mixtures and formulas.

  8. Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles 8/8/2023

    As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

  9. Your Digital QC Companion For Sterility Testing 8/13/2024

    Discover software designed to ensure fully accurate data recording in sterility testing and that complies with 21 CFR Part 11 standards for electronic records and signatures.

  10. Contamination Control Strategy With QRM Principles 11/19/2024

    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.