Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy
Download in electronic PDF format for $75
Abstract: Undeniably, one of the most important considerations in a compounding pharmacy’s procedures is quality. Developing a comprehensive quality-control potency program must begin with the most basic activities performed at a compounding pharmacy to the most crucial activities. If the basics are not met, the crucial activities of compounding sterile and non-sterile preparations and the quality of the end product are in jeopardy. Basic definitions are provided in this article as well as a discussion on a three-step method on setting up a quality-control potency testing program, to include (1) process design and how to reduce the potential of variations and mistakes in compounded preparations, (2) process verification, and (3) how to set up a sampling plan to monitor ongoing quality. Also included are suggestions on how to get started on the development of a quality-control potency testing program.
Related Keywords:
William J. Zolner, PhD, quality control, quality assurance, potency testing, compounding mistakes, process design, sampling plan
Related Articles from IJPC |
Title/Author
(Click for Abstract / Details / Purchase) |
Issue/Page
View/Buy |
Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy
Zolner William J
|
Sep/Oct 2009
Pg. 412-418
|
Applying Quality of Design Concepts to Pharmacy Compounding
Timko Robert J
|
Nov/Dec 2015
Pg. 453-463
|
Quality-Control Analytical Methods: High-Performance Liquid Chromatography
Kupiec Thomas C
|
May/Jun 2004
Pg. 223-227
|
Quality-Control Analytical Methods: Glossary of Quality Control/Quality Assurance Terms in Pharmaceutical Compounding
Kupiec Thomas C, Okeke Claudia, Allen Loyd V Jr, Denison Clay
|
Jul/Aug 2005
Pg. 300-302
|
Quality Control Analytical Methods: A Guide to Quality Control Testing for the Compounding Pharmacist
Zolner William J
|
Jul/Aug 2006
Pg. 281-284
|
Quality-Control Analytical Methods: Gas Chromatography
Kupiec Thomas C
|
Jul/Aug 2004
Pg. 305-309
|
Quality-Control Analytical Methods: Stability Versus Potency Testing: The Madness is in the Method
Kupiec Thomas C, Skinner Rodney, Lanier Lance
|
Jan/Feb 2008
Pg. 50-53
|
Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
McElhiney Linda F
|
Jul/Aug 2013
Pg. 307-311
|
Quality-Control Analytical Methods: Specific-Gravity Determinations of Liquids and Semisolids
Allen Loyd V Jr
|
Nov/Dec 2003
Pg. 477-480
|
Quality-Control Analytical Methods: Selecting an Analytical Method
Allen Loyd V Jr
|
Jan/Feb 2004
Pg. 61-64
|
Quality Assurance and Quality Control, Part 2
Akers Michael J
|
May/Jun 2015
Pg. 215-221
|
Quality Control Analytical Methods: Strategies to Ensure a Robust Quality-control Microbiology Program
Griffiths Tricia, Connors Anne
|
Mar/Apr 2013
Pg. 130-134
|
Quality Control Analytical Methods: Method Validation
Klang Mark G, Williams LaVonn A
|
Sep/Oct 2016
Pg. 381-386
|
Quality-Control Analytical Methods: In-House Quality Control of Simple Compounds
Trusley Craig
|
Nov/Dec 2007
Pg. 487-490
|
Quality-Control Analytical Methods: Osmolality and Osmometry
Allen Loyd V Jr
|
Mar/Apr 2004
Pg. 143-145
|
Quality Assurance and Quality Control, Part 1
Akers Michael J
|
Mar/Apr 2015
Pg. 121-124
|
Quality Control: Rapid Sterility Testing for Compounding Pharmacies
Taylor Andrew
|
Jul/Aug 2020
Pg. 299-303
|
Quality Control: Testing for "Micromonsters": Viable Air and Surface Sampling in Aseptic Compounding
Mulder Kyle
|
May/Jun 2021
Pg. 211-216
|
Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1
Vu Nicole, Lou Jessica R, Kupiec Thomas
|
May/Jun 2014
Pg. 213-221
|
Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations
Kupiec Thomas C
|
Mar/Apr 2005
Pg. 136-138
|
Return to Top |