About FDA

Guidance and Manuals


Guidances for Industry

Guidances for Industry promote understanding of, and compliance with, Good Manufacturing Practice (GMP) requirements.


QandA's provide a prompt and succinct guidance mechanism to enhance understanding of GMP expectations.

Guides to Inspection

These guides are reference materials for inspectional personnel.

Other Related Guides and Manuals

FDA publishes various other manuals and guides regarding our inspection and compliance work.

Page Last Updated: 11/27/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English