This guideline, issued under 21 CFR 10.90, states principles and practices of general applicability that are not legal requirements but are acceptable to the Food and Drug Administration (FDA). A person may rely upon it with assurance of its acceptability to FDA or may follow different procedures. Any person who chooses different procedures may, but is not required to, discuss the matter in advance with FDA to preclude expending money and effort on activity that FDA may later determine is unacceptable.

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Biotechnology Inspection Guide (11/91)

This Guide was initiated by Robert C. Fish, Director, Division of Field Investigations (DFI). Mr. Fish asked Barbara-Helene mith, Ph.D., DIB, CHI-DO, to chair a workgroup to develop inspectional guidelines for Investigators in the area of biotechnology. The workgroup, which also included Thaddeus T. Sze, Ph.D., Chemical Engineer, DFI, and Kim A. Rice, Supervisory Investigator, SEA-DO, prepared a draft document with information obtained from FDA Center and Field personnel who are actively involved in biotech inspections.

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Upcoming Conferences

	2016 ISPE 25th Aseptic Conference 29 February 2016 - 01 March 2016 Crystal Gateway Marriott ARLINGTON, VA USA
	2016 European Annual Conference 07 March 2016 - 09 March 2016 Frankfurt, Germany
	2016 China Spring Conference 10 April 2016 - 11 April 2016 Crowne Plaza Shanghai Noah Square Shanghai, China
	2016 ISPE Continuous Manufacturing 20 April 2016 - 21 April 2016 Hilton Baltimore BALTIMORE, MD USA