Define FDA. FDA synonyms, FDA pronunciation, FDA translation, English dictionary definition of FDA. abbr. Food and Drug Administration American Heritage® Dictionary of the English Language, Fifth Edition. Copyright © 2016 by Houghton Mifflin Harcou
3. Failure to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms [21 CFR 211.165(b)]. Specifically, you failed to perform appropriate laboratory testing, including sterility and endotoxin testing, on at least(b)(4...
More Commonly Misspelled Words Popular in Wordplay See All More Words with Remarkable Origins 8 Words for Lesser-Known Musical Instruments Birds Say the Darndest Things 10 Scrabble Words Without Any Vowels 12 More Bird Names that Sound Like Insults (and Sometimes Are)...
10、用的比率和范围没有明显差异API品种推荐/ANDA申报和CGMP认证支持/药品出口贸易渠道整合Generic Drug 非专利药Definition 非专利药的定义A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and ...
Under the previous definition, bulk drug substance was defined to mean “any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does...
美国FDA药品标签法规要求 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
In computer science, validation refers to ensuring that software meets its requirements. However, this may not meet the definition of process validation as found in guidance for industry Process Validation: General Principles and Practices: “The collection and evaluation of data … which establishes ...
9 For purposes of this guidance, the term quality unit is synonymous with the term quality control unit. For the definition of quality control unit, see § 210.3(b)(15). 9 在本指南中, "质量部门" 一词是 "质量控制部门" 一词的同义词。有关质量控制部门的定义, 请参见§ 210.3(b)(15)。
Biological Characteristics of the Drug Product This section should summarize the studies conducted and the results obtained for the following attributes; dose proportionality, bioavailability and bioequivalence. Process Definition Section This section should provide information on the theoretical unit formula per...
The FDA (U.S. Food and Drug Administration) is an agency within the U.S. Department of Health and Human Services (HHS) that oversees the manufacturing and distribution of food, pharmaceuticals, medical devices, tobacco and other consumer products and veterinary medicine. ...