Regulatory Compliance Featured Articles

  1. Viral Safety Approaches For Advanced Therapy Medicinal Products

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

  2. Regulations For Mapping Temperature And Humidity Of Pharmaceuticals

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

  3. Choosing Sensors and Parameters For Mapping In Life Sciences

    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.

  4. Calibration, A Critical Success Factor For Mapping In Pharma Manufacturing

    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.

  5. Mapping Strategy Fundamentals For Regulatory Compliance

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

  6. Making Sense Of Sensor Numbers And Placement

    There are many factors that are in play for the number of sensors required. It would be nice if there was a simple formula such as one sensor per square foot or per square meter.

  7. Monitoring Mistakes: Avoid The Most Common Mapping Issues

    In spite of the headline, it is difficult to pin point the one single most common mistake. This articles focuses on what not to do, or what to avoid, during the mapping process.

  8. What Does "Child Resistant Packaging" Mean In Pharma?

    Child resistant packaging intergrates the use of safety mechanisms and physical barriers to reduce the risk of poisining in children via the ingestion of potentially hazardous medicines.

  9. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.

  10. Incorporate Data Integrity Into Your Pharma Quality Management System

    A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable.