Implementing Risk Managed Supplier Quality
A risk-managed approach to the global supply chain is more important than ever for life science manufacturers....
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GMPs for Early Stage Development Projects
Good Manufacturing Practices (GMPs) should be implemented during the later stages of clinical development, where the final...
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,...
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...
Animal Testing
Traditionally, animals have been used as test subjects during drug development studies to reliably detect the toxic...
Meeting the Requirements of 10.4 of MDR How to Address CMRs
Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the...
Establishing Bioburden Alert and Action Levels
In the realm of bioburden, sterilization, and environmental testing, national and international standards play a crucial role...
The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed
When selecting and qualifying the primary packaging for lyophilized drug products, an essential question arises: How comprehensive...
Good Identification Practices For Organic Extractables & Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....
DISINFECTION VALIDATION: How to Classify and Validate Your Medical Device Disinfection Process
Reprocessing reusable medical devices involves cleaning, disinfecting, and sterilizing them to ensure they are safe and effective...
