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Big Changes for USP
Because of the potential impacts on testing and compliance, these revisions require careful evaluation by pharmaceutical manufacturers, their suppliers, and contractors. Timely industry review of the proposal is needed to meet the ambitious timeline planned by USP for review and implementation.
Significant changes in content are also proposed, including a plan to share the same General Notices for five different publications. In addition to the USP and NF, USP now publishes the Food Chemicals Codex (FCC) and two online publications:
Adopting the same General Notices for all of these publications requires careful consideration to ensure their appropriate use.
Another major change concerns a new definition of official, which may affect the regulatory status of articles and interpretation of requirements. Because the term official compendium is defined in the Food, Drug and Cosmetic (FD&C) Act to include the USP and NF, but not the other publications, care is needed to avoid confusion. In a related initiative, USP is also considering changing the status of some general chapters, so that some non-mandatory sections might be made mandatory, and vice versa.
The URL (www.usp.org/USPNF/generalNotices.html) links to the revisions of both the USP-NF and the FCC General Notices and describes the timeline for review and comment.
Industry participation urged
Industry members are encouraged to review the revised USP General Notices with experts in their organizations to identify areas of concern and provide comments to USP. In addition, a project team sponsored by the USP invites feedback from affected parties to formulate a detailed user response to the proposed revisions.
The General Notices Project Team requests feedback by Oct. 31, 2007. Comments should be sent to Neil Schwarzwalder, firstname.lastname@example.org
Neil Schwarzwalder is a global compendial consultant for Global Quality Laboratories, Eli Lilly and Company, tel. 317.276.9787 fax 317.433.0268