Pharmaceutical Manufacturers To Benefit From Consistency And Clarity

Main Category: Pharma Industry / Biotech Industry
Article Date: 22 Oct 2009 - 0:00 PDT

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To improve key documentation relied upon by the pharmaceutical industry and others, the U.S. Pharmacopeial (USP) Convention announces the release of the redesigned United States Pharmacopeia-National Formulary (USP-NF). The new format brings consistency and clarity to language and formats used throughout the publication, greatly improving ease of use. USP has produced this book of written standards for the identity, quality, purity, and strength of medicines and their ingredients since 1820. Official compendial standards such as those in the USP-NF are written into United States law as part of the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act of 1938. The current redesign marks the first time that all monographs in the USP-NF appear in a consistent, coordinated format.

"USP has been setting pharmaceutical standards for almost 200 years, and the terminology and formatting used in our collection of monographs reflect many different eras and editorial styles," said Susan de Mars, USP's chief documentary standards officer. "This redesign brings consistency to the language used throughout the book and weaves the text into a new outline and format that makes it easier for readers to find - and to understand - what they're looking for."

Customers and other users of the USP-NF have provided extensive input for the redesign over the past few years. Working with this input and members of the volunteer USP Council of Experts, USP staff developed a new template with the primary goal of enhancing usability. Changes include:

• Language: Language and technical terms have been changed throughout the book to reflect contemporary usage. Descriptions are more concise, and ICH terminology has been incorporated.
  
  
• Cross-references: Common tests, procedures and acceptance criteria are repeated across relevant monographs as needed, minimizing unnecessary cross-referencing.
  
  
• Format: To make the book uniform and easier to follow, the sections for each monograph are now consistent throughout, as are typefaces and spacing.
  
  
• Clarification of solutions: Less detailed solution preparations, shortened where possible to define only the final concentration in SI units.

The current redesign has focused only on language and formatting. Any potential changes to scientific content are treated separately for each monograph through the processes described at http://www.usp.org/USPNF/. The redesigned format will be incorporated in USP 33-NF 28 in November 2009.

Source:
Francine Pierson
US Pharmacopeia