Putting the Science Back into the "Art and Science" of Compounding
Download in electronic PDF format for $65
Abstract: Acceptance of the revised standards for compounding sterile preparations published as United States Pharmacopeia Chapter <797> has met with a significant amount of resistance, mainly owing to the expense of compliance. These standards owe much to the expanded perspective of the United States Pharmacopeia Council of Experts Sterile Compounding Committee, which was responsible for the revision. Because it is widely accepted by those in the pharmaceutical industry that compounding facility design, environmental control, and personnel have direct effects on the sterility of aseptically compounded preparations, the committee drew from expertise in pharmacy as well as fields outside pharmacy, such as microbiology, infection control, and engineering controls. How “science” from other disciplines has been incorporated into the in-process revision of United States Pharmacopeia Chapter <797> is reviewed.
Related Keywords:
Eric S. Kastango, RPh, MBA, FASHP, compounded sterile preparations, United States Pharmacopeia Chapter <797>, microbial contamination, engineering controls, environmental monitoring, air quality, quality assurance, compounding
Related Categories:
STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS
Printer-Friendly Version
Related Articles from IJPC |
Title/Author
(Click for Abstract / Details / Purchase) |
Issue/Page
View/Buy |
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards
Kastango Eric S
|
May/Jun 2008
Pg. 216-229
|
Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
|
Mar/Apr 2021
Pg. 115-124
|
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 6: 2008 Revisions to Chapter <797>
Allen Loyd V Jr, Okeke Claudia C
|
Mar/Apr 2008
Pg. 136-144
|
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
|
Mar/Apr 2020
Pg. 92
|
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control
Allen Loyd V Jr, Okeke Claudia C
|
May/Jun 2009
Pg. 234-238
|
Basics of Sterile Compounding. Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2
Martin Matt
|
Nov/Dec 2018
Pg. 475-478
|
Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
Martin Matt
|
Sep/Oct 2018
Pg. 401-404
|
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 14: Environmental Quality and Control (Continued)
Okeke Claudia C, Allen Loyd V Jr
|
Jul/Aug 2009
Pg. 322-329
|
Quality Control: Testing for "Micromonsters": Viable Air and Surface Sampling in Aseptic Compounding
Mulder Kyle
|
May/Jun 2021
Pg. 211-216
|
Adventures in the Environmental World and Environmental Microbiology Sampling of Air for Pharmaceutical Sterile Compounding
Ligugnana Roberto
|
May/Jun 2017
Pg. 182-190
|