Search results for " quality" in Articles / App Notes
Article
Best Practices in Qualification of Single-Use Systems
There are many factors to be evaluated, including technical assessment, supply chain, business aspects, and supplier quality. PDA
Technical Report No. 66, Application of Single-Use Systems in Pharma…
Article
Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…
Article
Moving PAT from Concept to Reality
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors needed for the measurement of critical product quality attributes and product-related species are not commercial…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…
Article
QbD Improves Cell-Culture Process Control
However, using a quality-by-design (QbD) approach that employs predictive modeling can improve the quality of end product as well as the efficiency of the bioprocess.
Real-time quality control
…
Article
Unifying Continuous Biomanufacturing Operations
…odels that could eliminate scale-up altogether; test the consequences of continuous lines on product quality and stability; and consider what vendor gaps exist that could preclude a completely end-to…
Article
Being Thorough When Transferring Technology
Other examples are unexpected low titer compared to process development runs or unexpected filter clogging in depth-filtration steps due to different quality of filtration starting material. An exampl…
Article
Global Expansion Shapes Drug Oversight
…g global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. To better assess product risks, Hamburg proposed “enhanced int…
Article
Manufacturers Struggle with Breakthrough Drug Development
Demonstrating efficacy is not the problem, she noted; the greater challenge is to ensure quality manufacturing and access to needed diagnostics.
CMC issues
FDA grants breakthrough status f…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
In Part I of this series, the author introduced the concept of continuum of criticality and applied it to the concepts of critical quality attributes (CQAs) and critical process parameters (CPPs). In …