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: PAC-ATLS: Post approval Changes - Analytical Testing Laboratory Sites, April 1998


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
FDA Guidance
This FDA guideline regulates under what conditions the change made to an analytical laboratory is possible and in what form the FDA must be informed.

Go back

GMP Conferences by Topics