PAT
The United States Food and Drug Administration (FDA) recognized that regulatory barriers have inhibited adoption of state-of-the-art manufacturing practices within the pharmaceutical industry. A new risk based approach for Current Good Manufacturing Practices (cGMP) looks to modernize the regulation of pharmaceutical manufacturing.
The FDA's initiative is built on the premise that if manufacturers can demonstrate understanding of their processes, they are at less risk of making bad product. Manufacturers can also benefit from new freedoms allowing them to implement improvements based on their process knowledge without the need for regulatory review.
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The United States
Food and Drug Administration
(FDA) recognized that regulatory barriers have inhibited adoption of state-of-the-art manufacturing practices within the pharmaceutical industry. A new risk based approach for
Current Good Manufacturing Practices
(cGMP) looks to modernize the regulation of pharmaceutical manufacturing.
|
|
The FDA's initiative is built on the premise that if manufacturers can demonstrate understanding of their processes, they are at less risk of making bad product. Manufacturers can also benefit from new freedoms allowing them to implement improvements based on their process knowledge without the need for regulatory review.
|
Implementation in SIMCA and SIMCA-online
Consolidate process and spectroscopy data for multivariate process modeling and monitoring
(3 pages, 992 kB)
Implementation of DoE approaches in the QbD framework
Examples from Evonik:
Pharma Polymers News (8 pages, 1.7 MB)
Quality by design approach to optimize in-process curing of EUDRAGIT NM 30 D (1 page, 4.2 MB)
