GUIDELINE FOR THE DETERMINATION OF RESIDUAL MOISTURE IN DRIED BIOLOGICAL PRODUCTS
Prepared by: Center for Biologics Evaluation and Research Division of Biochemistry and Biophysics Laboratory of Analytical Chemistry (HFB-740) Food and Drug Administration 8800 Rockville Pike Bethesda, MD 20892 301-496-4570 Comments regarding these analytical methods should be submitted to Docket Management Branch (HFA-305), Food and Drug Administration, Rm 4-62, 5600 Fishers Lane, Rockville, MD 20857. Comments should be identified with [Docket No. 89D-0140]
Introduction This guideline is issued under 21 CFR 10.90, and as such, it 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 this guideline with the assurance of its acceptability to FDA, or may follow different procedures. When different procedures are chosen, a person may, but is not required to, discuss the matter in advance with FDA to prevent the expenditure of money and effort on activity that may later be determined to be unacceptable.
The guideline is issued concurrently with a final rule that amends the test for residual moisture in dried biological products found in 21 CFR 610.13 of the biologics regulations. The guideline may be revised and updated after the agency reviews and evaluates comments submitted by interested persons.
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