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INFLUENCE OF THE USP ON THE DRUG APPROVAL PROCESS. Gourish Chakarvarty, A C Rana, Gurpreet Singh, Nimrata Seth, Rajni Bala, Seema Saini

INFLUENCE OF THE USP ON THE DRUG APPROVAL PROCESS.

Gourish Chakarvarty, A C Rana, Gurpreet Singh, Nimrata Seth, Rajni Bala, Seema Saini

International Journal of Natural Product Science 2012: Spl Issue 1:48.

Abstract (RBIP-48)

The role of USP (inception 1820) and NF (inception 1888) has always been to establish public standards for purity, quality and strength for medicinal articles and compounding information. In the earliest days USP was a private, nongovernmental organization without any legal status until 1900. Currently the USP/NF monograph is recognized in federal statutes as a drug standards-setting body. Both the USP and NF developed publication cycles for revisions, with interim revision announcements. The USP/NF continues to serve the health-care–delivery system by providing public standards for pharmaceutical and dietary supplements. It is critical for USP actions to assure that monographs and informational (both mandatory and optional) reflect current scientific technology and that the contents of the USP is in line with EP and JP standards and meets FDA expectations. All official articles (active or inactive ingredients or preparations or drug products) dictate that the user must assure that the articles are fully compliant with all specified USP/NF monograph requirements and ancillary compendia Requirements. It is critical that the industry maintain strong vigilance and interaction with USP to make sure that the public standards satisfy the needs of stakeholders and the regulatory sector.

Keywords: USP, NF, monograph
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