2024年10月16日 · USP General Chapter describes a number of requirements, including responsibilities of compounding personnel, training, facilities, environmental monitoring and …

Greater care is required for aqueous injections that are compounded sterile preparations (CSPs) the most common CSPs used in therapy. Aqueous injections for administration into the …

The following represents key changes from the currently enforceable version of USP Chapter <797> (last major revision in 2008) to the revised USP Chapter <797> (official as of November …

Revision Bulletin 〈797〉 Pharmaceutical Compounding—Sterile Preparations 1 Change to read: 〈797〉 PHARMACEUTICAL COMPOUNDING—STE RILE PREPARATIONS …

2019年6月1日 · Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug or bulk drug substance to create a …

2020年4月8日 · Established by the United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, USP …

The appropriate risk level low, medium, or high is assigned according to the corresponding probability of contaminating a CSP with (1) microbial contamination (microbial organisms, …

Analyze the USP <797> requirements for documentation pertaining to all aspects of sterile compounding including Standard Operating Procedures (SOPs), Master Formulation Records …

This chapter describes the minimum standards to be followed for the preparation of compounded sterile preparations (CSPs) for human and animal drugs. Sterile compounding is defined as …

US Pharmacopeia (USP)