Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

How to Qualify Container Closure Systems for Intended Use, Part 1

Author(s):  Kim Amy A, Gehrmann Matthew R, McCaw James, McAndrew T Page

Issue:  Nov/Dec 2019 - Volume 23, Number 6
View All Articles in Issue

Note:  Electronic version includes errata or revisions.

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, need to focus on qualifying container closure systems for their intended use. Container closure systems must be fit-for-purpose (i.e., suitable for in-use conditions relative to drug product stability over intended shelf-life and storage conditions). This article, the first of a two-part series, addresses the critical aspect of how to qualify systems for intended use regarding container closure integrity. The second part will address component selection.

Related Keywords: Amy A. Kim, BS Biology, Matthew R. Gehrmann, BS Chemistry, James McCaw, BS Chemistry, T. Page McAndrew, PhD Chemistry, drug container closures, drug contamination, drug safety regulations, Current Good Manufacturing Practice, CGMP, Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, 503B status, container closure integrity, fit for purpose, intended use, maximum allowable leak limit, sterile compounding, United States Pharmacopeia <1207> Packaging Integrity Evaluation--Sterile Products, USP, vial systems, stopper systems, seal systems, helium leak method, oxygen headspace method, residual seal force method, compression, microbial contaminants, drug contamination


Printer-Friendly Version

Download in electronic PDF format for $65

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
How to Qualify Container Closure Systems for Intended Use, Part 1 Kim Amy A, Gehrmann Matthew R, McCaw James, McAndrew T Page Nov/Dec 2019 454-461 Buy
Does Your Drug Expertise Include Clinical Pharmaceutics? Newton David W May/Jun 2016 202-206 Buy
Quality Control: Personal Protective Equipment for Use When Handling Hazardous Drugs Dillon L R Jan/Feb 2020 30-36 Buy
Documentation: Records and Reports Akers Michael J Sep/Oct 2017 373-380 Buy
Basics of Compounding for Hazardous Drugs, Part 2: Regulation and Sources of Contamination Allen Loyd V Jr Nov/Dec 2006 446-448 Buy
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Allen Loyd V Jr Sep/Oct 2017 356 Buy
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Parks Kenneth Chase, Bernard Brian, Cogdill Christopher Blake Sep/Oct 2015 377-380 Buy
Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A Blankenship Cynthia E Sep/Oct 2014 379-380 Buy
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Allen Loyd V Jr Jul/Aug 2016 351 View Sample
Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Allen Loyd V Jr May/Jun 2013 210-219 Buy
Particle Measuring Systems - USP <797> Environmental Monitoring Solutions