The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process. Description of USP <800> “USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. Suggested audience: Suppliers and manufactures of drug substance, drug products, excipients, contract manufacturing organizations, drug testing organizations and drug products related regulatory agencies, QA/QC specialists, Estimated proposal PF:  Pharmacopeial Forum 46(5) [Sep.–Oct. Developing USP General Chapter <795> USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The following lists (and links to) the USP-NF general chapters … Important Note: The currently official version of General Chapter <795> (last revised in 2014) remains official. //--> provides standards for compounding quality nonsterile preparations. However, preparation instructions for many reagents were carried forward from the innovator's laboratories to the originally introduced monograph for a particular USP–NF article or general test chapter. Background and objective(s):  USP intends to develop a new informational general chapter to align with current scientific and regulatory approaches to provide information useful for ensuring the appropriate control of nitrosamine impurities in drug substances and drug products. fault conditions for the interpretation and application of the2.20. The chapter provides suitable performance criteria for analytical procedures used in the Identification and quantification of nitrosamine impurities. ‘Applicable general chapters’ refers to the general chapters numbered below 1,000 in USP–NF that are made applicable to an article through reference in General Notices, a monograph, or another applicable general chapter numbered below 1,000. The USP Compounding Expert Committee is responsible for the development of General Chapter <795>. [CDATA[// >

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