United States Pharmacopeia guidelines

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. 

US FDA, CDER Guidance Documents US FDA, CBER Guidelines US FDA Warning Letters United States Pharmacopeia WHO... 

USP (1074) excipient biological safety evaluation guidelines. In United States Pharmacopeia, 24th Ed. US Pharmacopeial Convention Inc. Rockville, 2000 2037. 

Some organizations, including the Canadian Health Protection Branch and the United States Pharmacopeia (USP), act as observers to the conference working committees, and their input is also influential in the guideline-setting process. In addition, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) acts as an umbrella organization and provides the ICH secretariat to coordinate the preparation of documentation. 

The full utility of this Guideline is dependent on the successful completion of harmonization of pharmacopoeial procedures for several attributes commonly considered in the specification for new drug substances or new drug products. The Pharmacopoeial Discussion Group of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia has expressed a commitment to achieving harmonization of the procedures in a timely fashion. 

Storage conditions should be specified on the label of API containers when it is critical to maintain such conditions to ensure the quality of the API. Where applicable, labeled storage conditions should comply with standard definitions for Freezer, Cold, or Controlled Room Temperature, as defined in the United States Pharmacopeia (USP) or guidelines of the International Conference on Harmonisation (ICH). Statements of specific storage conditions should be used instead of more general terms such as room temperature when it is critical for maintaining the quality of APIs. 

United States Pharmacopeia (USP) Storage Temperature Guideline... 

CMS will rely on United States Pharmacopeia (USP) to develop model guidelines for drug categories and classes. PDP may adopt these model guidelines or develop their... 

United States Pharmacopeia (USP) A federal agency who is responsible for all standards, limits, methods, and guidelines for aU pharmaceutical products made in the United States. After a 4-year review and approval process, it has just published Chapters <232>, <233>, and <2232> for the determination of elemental impurities in pharmaceutical products and dietary supplements, as a replacement for Chapter <231>, a 100-year-old colorimetric test for heavy metals. 

This guideline mainly addresses the harmonization of monographs for commonly used excipients, across the United States, European, and Japanese pharmacopeias. Prior to harmonization, manufacturers were required to perform different or replicate tests with different acceptance criteria on many... 

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