Regulatory Compliance Featured Articles

  1. Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities
    9/21/2017

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.

  2. Understanding And Delivering Your EU Orphan Drug Launch
    8/25/2017

    Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge if you are not familiar with country specific requirements. Read more about Understanding and delivering your EU Orphan Drug Launch

  3. Solving the OOS Problem with Continuous Manufacturing
    8/13/2017

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.

  4. Autologous Cell Therapies At Crossroads With FDA: What To Do Now?
    7/25/2017

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

  5. How To Prepare For Chamber Mapping In Life Sciences – 8 Critical Steps
    7/17/2017

    Most chamber mapping projects that fail do so because of inadequate preparation. Poor or inadequate preparation for the mapping study can lead to a failed mapping study, which can lead to unnecessary costs in valuable biopharmaceutical production time or regulatory and product quality issues.

  6. Viral Safety Approaches For Advanced Therapy Medicinal Products
    7/11/2017

    Manufacturers safeguard biologic materials during the development process through a set of measures commonly referred to as the “Safety Tripod.”

  7. Regulations For Mapping Temperature And Humidity Of Pharmaceuticals
    6/26/2017

    There are several guidelines from a myriad of agencies around the world that are available that cover Environmental Monitoring and Mapping In life sciences?

  8. Choosing Sensors and Parameters For Mapping In Life Sciences
    6/26/2017

    The parameters you choose to map in drug development and processing will depend upon your particular situation. Typical parameters for mapping are temperature, humidity, pressure, light and vibration. You must first determine the environmental parameter(s) critical to your system, process, and product. Assuming you are operating in a regulated environment, the critical parameters are most likely already documented in your cGMP files.

  9. Calibration, A Critical Success Factor For Mapping In Pharma Manufacturing
    6/26/2017

    A decision about making, or not making, a pre or post calibration check can be the difference between a successful study or a time consuming failure.

  10. Mapping Strategy Fundamentals For Regulatory Compliance
    6/26/2017

    In order to comply with regulatory mandates in the manufacture of pharmaceuticals, you need a mapping strategy several reasons.