Search results for " detection"
Article
Design of Experiments for Analytical Method Development and Validation
…t and identify factors that may influence precision, accuracy, linearity, signal to noise, limits of detection and quantification, and/or any other assay attributes to achieve optimal assay results. …
Article
Regulatory Challenges in the QbD Paradigm
…duct monitoring, and evaluate process analytical technology and in-line or at-line sensors for early detection of microbial contamination. There is even the possibility of real-time release through t…
Article
Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
Quality risk management (QRM), as defined in Internatio…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…