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How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems

Author(s):  Vaughn Stacey R, Radwick Allison

Issue:  Jan/Feb 2020 - Volume 24, Number 1
View All Articles in Issue

Page(s):  14-19

How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems Page 1
How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems Page 2
How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems Page 3
How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems Page 4
How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems Page 5
How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems Page 6

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Abstract:  The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, must now focus on qualifying container closure systems for their intended use. This article, the second in a two-part series, examines component selection and methods for demonstrating that the container closure system will protect and maintain the quality of the compounded drug and ensure that the compounded drug can be safely administered to a patient.

Related Keywords: Stacey R. Vaughn, BA Chemistry, Allison Radwick, RPh, PhD Pharmaceutical Sciences, outsourcing facilities, container closure system qualification, drug packaging, U.S. Food and Drug Administration, FDA, injectable dosage forms, compounded sterile preparations, suitability, compatibility, safety, performance, testing methods, stability

Related Categories: LEGAL, PACKAGING, PARENTERALS, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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