The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance

Short Title:
Process Analytical Technology FDA Guidance

Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,

Document Type:
FDA Guidance for Industry
This guidance is intended to describe a regulatory framework that will encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.

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