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The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopoeial Convention. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the U.S.A. and many other nations. Therefore, in case of a dispute, those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.

Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.

Who Needs USPNF

USPNF is essential in the following types of industries:

Pharmaceuticals prescription and nonprescription drugs

Biological and biotechnology products

Blood and blood products

Cosmetics

Dietary supplements

Excipients/other drug ingredients

Medical devices

Medical gases

Veterinary drugs

In each of these industries, USPNF is an essential resource for scientists, managers, supervisors, and directors in:

Quality control

Quality assurance

Regulatory/compendial affairs

Research and development

Method development/analytical services

Corporate management

USPNF also is an important reference for pharmacies, libraries, universities, and schools of medicine and pharmacy.

How USPNF Helps

Only the USPNF provides the official standards enforceable by the U.S. Food and Drug Administration for drugs and related products manufactured and marketed in the United States. In addition, it serves as a clear, step-by-step guide for the specificationstests, procedures, and acceptance criteriarequired for pharmaceutical manufacturing and quality control.

USPNF helps to:

Ensure compliance with official standards

Work to world-recognized standards of precision and accuracy

Validate test results against proven benchmarks

Establish and validate in-house standard operating procedures, procedures, and specifications

Expedite new product development and approvals

Book Info:

Published in 2007

ISBN 1889788473 Size 44.00MB

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