PAT and Quality Improvement Library
The PAT and Quality Improvement Library
Quality by Design describes a system in which quality is designed into a product (in this case, a pharmaceutical) rather than being tested in after production. The concept of quality by design requires the use of statistic methods and analytics (including the tools collectively known as Process Analytical Technologies) to gain understanding of processes, which can be used to optimize and control them.
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- Online Reaction Monitoring of Inprocess Manufacturing Samples by UPLC
Process Analytical Technology (PAT) is a critical component in manufacturing, relied upon to ensure product quality and improve process yields. Here we discuss the use of novel Waters technology for online reaction monitoring of inprocess manufacturing samples, which allows for simultaneous quantification of APIs and process impurities.
- Pharmaceutical Manufacturing: Is It the Antithesis of Creative Destruction?
PAT and QbD can only move forward if the industry sheds its habit of QbA (i.e., quality by analysis)
- Multivariate Calibration: A Science-Based Method
A new method for multivariate calibration is less costly to implement than standard PLS or PCR methods, and eliminates the need to introduce additional variability into an otherwise stable process. It also allows specific responses to be proven from first principles.
- The Business Case for PAT
Having trouble justifying PAT projects to top management? The business drivers for PAT are compelling, both on the regulatory and on the financial side. This Rockwell Automation white paper discusses how to conduct a “productivity improvement appraisal” and how to handle discovery and analysis phases of any PAT project.
- PAT Needs and Applications in the Bioprocess Industries
In this comprehensive report, the authors examine what PAT means in practice for the biotechnological manufacture of pharmaceuticals. They analyze regulatory issues, monitoring methods and available technologies, and compare their findings against the needs for monitoring in bioprocess-based pharmaceutical production.
- Chemometrics Basics
Using chemometric algorithms, modern computer technologies and rapid spectroscopic analysis, provides the basis for the modern-day development of methods of chemical analysis with the best rewards.
- Demystifying Multivariate Analysis of Umetrics
In order to identify sources of process variability, you need to be able to integrate information ranging from raw material and intermediate measurements to processing and environmental data. Multivariate analysis techniques such as principle component analysis (PCA) and partial least squares (PLS) can be highly effective. Chris McCready, an engineering specialist with the software firm UMetrics, shows how MVA methods can be applied to improve your process IQ.
- More Whitepapers...
- “PAT Talk” with Jack Carroll and Emil Ciurczak
- Analytical Instrumentation Qualification in a PAT/QbD World
- The Pharma Quality Lifeline
- Financial Matters for PAT/QbD Teams, Part 1 of 2
- Financial Matters for PAT and QbD Teams, Part 2 of 2
- "PAT Talk" with Anjali Kataria
- "PAT Talk" with David Radspinner
Videos and Podcasts
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Submit Information on PAT and Quality Improvement
Have you developed expertise in PAT, Quality by Design or any facet of quality improvement as it pertains to pharmaceutical scaleup and manufacturing? Would you like to share best practices and lessons learned with your colleagues around the world? If so, please let us know and send us a draft of the article, or a 250-word abstract summarizing what you'd like to write about. We'll use that to develop the article for publication and/or add it to this online library. Please send your abstracts or articles to firstname.lastname@example.org.