Component Selection for Sterile Compounding
Author(s): Dilzer Richard H
Issue: Jul/Aug 2017 - Volume 21, Number 4
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Page(s): 277-280
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Abstract: This article describes the factors to consider, as well as the process of proper component selection, for use in preparing compounded sterile preparations. Special emphasis is placed on individual chemical factors that may impact a preparation’s accuracy and potency. Values reported in a typical certificate of analysis are discussed, including methods of identifying any required adjustments to a master formulation or compounding record during the compounding of sterile preparations. Proper screening of the certificate of analysis, the Safety Data Sheet, procedural documentation, and the filing of all certificates of conformance are crucial to the operation of a sterile compounding facility.
Related Keywords: compounded sterile preparations, certificate of analysis, documentation, standard operating procedures, vendor, package integrity, good manufacturing practice, safety data sheet, United States Pharmacopeia Chapter <797>, United States Pharmacopeia Chapter <1160, USP, Compounding Compendium, potency, purity, quality control, loss on drying
Related Categories: EXCIPIENTS, SOPs, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS