The Food and Drug Administration issued the guideline “Guidance for Industry, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance” in September, 2004. The objective of this guidance was to “describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance.” The guideline identified four categories of tools that “provide effective and efficient means for acquiring information to facilitate process understanding, continuous improvement, and development of risk-mitigation strategies”
- Multivariate tools for design, data acquisition and analysis
- Process analyzers
- Process control tools
- Continuous improvement and knowledge management tools
Each year a number of conferences are held that serve as a platform for manufacturers to present the results of PAT implementations. For example, The QbD/PAT Conference 2010 was held last month. The 8th Annual PAT and Quality by Design conference is schedule early next year. However, industry has been slow to adopt PAT and the reasons for this are often the topic of articles and discussion groups. The issue is complex but industry and regulatory conservatism is often identified as a barrier to PAT acceptance. However, I believe that on closer examination more fundamental issues exist that discourage manufacturers from embracing PAT. Two examples are:
- Process Analyzers – In some cases spectral analyzers hold great promise in providing an on-line measurement of biological, chemical, and physical attributes e.g. secondary area. However, the DCS systems used in manufacturing often do not support the collection and use of spectral data. As the PAT guidelines pointed out on the subject of analyzers, “Ease of secure access to these data is important for real time manufacturing control and quality assurance.”
- Multivariate tools – Many of the commercial tools available today for multivariate analysis were originally designed to address off-line analysis. The integration of these products into a DCS control system for on-line use with a batch process can be challenging.
As part of the Life Science Industry Forum breakout session at Emerson Exchange 2010, I participated in a roundtable that addressed “Change in Pharma”. As part of the roundtable discussion, I presented work that is being done within Emerson to explore the integration of spectral analyzers into the control system. Also, information was provided on a field test and development of multivariate tools designed for on-line use in a batch manufacturing environment. If you are interested in learning more about these topics, then the viewer below may be used to access my roundtable presentation.
The viewer also allows you to download the power point file.