Quality Featured Articles

91. Container Closure Integrity Testing Utilizing Mass Extraction Technology 9/7/2017

    Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.

92. 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.

93. 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?

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

    A failed chamber mapping study can lead to unnecessary costs in valuable biopharmaceutical production time or regulatory and product quality issues.

95. 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?

96. 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.

97. 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.

98. 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. 

99. Making Sense Of Sensor Numbers And Placement 6/26/2017

    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.

100. Monitoring Mistakes: Avoid The Most Common Mapping Issues 6/26/2017

     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.