Cytotoxicity Failure What Now
Cytotoxicity testing is a critical endpoint for all medical devices that come into contact with patients or...
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Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges
Flexible bag systems for large volume parenterals (LVPs) are subject to stringent regulatory oversight for extractables and...
Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization
Medical device manufacturers using ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
Lyophilized drug products, also known as freeze-dried pharmaceuticals, require specialized containers and administration devices to ensure their...
Outsource Quality and Regulatory Agencies: Right-Sizing Need and Cost
Small or emerging life science organizations often face the dilemma of when to hire Quality and Regulatory...
Single Use & Newly Manufactured Device Cleaning Validations
Performing a cleaning validation during the initial phase of a device’s lifecycle is crucial for manufacturers to...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Challenges in Design Development – Why Design Control Makes Sense
The journey from a novel idea for a new medical product to its commercial realization involves significant...
Developing a Quality System on a Budget
Developing a robust quality system is fundamental to ensuring that an organization’s products or services are safe,...
GMPs for Early Stage Development Projects
Good Manufacturing Practices (GMPs) should be implemented during the later stages of clinical development, where the final...
