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###-Book Description Begin-###
USP-NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
USP 41 - NF 36 will come into force on 1st May 2018. It will be enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States.
The USP–NF offers convenient, comprehensive information for all phases of producing quality prescription, nonprescription, and compounded medicines; excipients; biologics; medical devices; and dietary supplements. It is essential for quality control, quality assurance, regulatory/compendial affairs, research and development, method development/analytical services, and corporate management. USP–NF monographs and methods can help to
Ensure compliance with required U.S. quality standards
Work to world-recognized standards of precision and accuracy
Validate test results against proven benchmarks
Establish and validate in-house standard operating procedures, and specifications
Expedite new product development and approvals
