Guidance for industry PAT — A framework for innovative pharmaceutical development, manufacturing and quality assurance
by FDA Center for Drug Evaluation and Research
This white paper by the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is a guidance for industry on process analytical technology (PAT) and represents the FDA's current thinking on this topic. It is intended to describe a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance. To a large extent, the paper discusses principles with the goal of highlighting opportunities and developing regulatory processes that encourage innovation. It explains the PAT framework, process understanding, principals, tools and strategy for implementation.
| Published: | 2004 |
| Format: | |
| Length: | 19 pages |
| Type: | White paper |
| Language: | English |
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