Abstract

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

Page(s): 14-19

Download in electronic PDF format for $75

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

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page View/Buy	Title/Author (Click for Abstract / Details / Purchase)
Nov/Dec 2019 Pg. 454-461	How to Qualify Container Closure Systems for Intended Use, Part 1 Author(s): Kim Amy A, Gehrmann Matthew R, McCaw James, McAndrew T Page
Jan/Feb 2020 Pg. 14-19	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
Jul/Aug 2021 Pg. 311-317	Basics of Sterile Compounding: Intravenous Admixture Preparation Considerations, Part 10: Packaging and Container-closure Issues Author(s): Allen Loyd V Jr
Nov/Dec 2015 Pg. 491-500	Basics of Sterile Compounding: Sterile Product Packaging and Delivery Systems Author(s): Akers Michael J
Sep/Oct 2021 Pg. 389-395	Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Author(s): Higgins Doral (Neal) O, Prudom Melanie J, Summers Amy
Jan/Feb 2020 Pg. 86-87 View Sample	Errata - How to Qualify Container Closure Systems for Intended Use, Part 1 - IJPC 23(6) 454-461 Author(s):
Sep/Oct 2015 Pg. 432-436	In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers Author(s): Bhattacharya Sisir, Parekh Satish, Dedhiya Mahendra
May/Jun 2014 Pg. 208	The U.S. Food and Drug Administration Responds to the International Academy of Compounding Pharmacists' Outsourcing Letter Author(s): Miller David G
Sep/Oct 2017 Pg. 356	PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs Author(s): Allen Loyd V Jr
Jul/Aug 2021 Pg. 298-302	Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 1 Author(s): Higgins Doral (Neal) O, Prudom Melanie J, Summers Amy
Jul/Aug 2016 Pg. 351 View Sample	Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Author(s): Allen Loyd V Jr
Jul/Aug 2015 Pg. 303-305	U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances Author(s): Miller David G
Nov/Dec 2015 Pg. 487-488	U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs Author(s): Allen Loyd V Jr
Mar/Apr 2014 Pg. 117-118	IACP's Continuing Support of Compounding Pharmacists: Letter to the FDA Concerning 503B Outsourcing Facilities Author(s): Miller David G
Mar/Apr 2018 Pg. 108-121	Personalized Medicine and Customized Drug Delivery Systems: The New Trend of Drug Delivery and Disease Management Author(s): Soni Abhishek, Gowthamarajan Kuppusamy, Radhakrishnan Arun
Jan/Feb 2017 Pg. 47-56	Basics of Sterile Compounding: Biopharmaceutics of Injectable Dosage Forms Author(s): Akers Michael J
Jan/Feb 2019 Pg. 32-33	U.S. Food and Drug Administration Inspection Authority: How to Know Whether U.S. Food and Drug Administration Inspectors Are Crossing the Line Author(s): Snow Stephen T, Stannard Robert W, Bellis Jennifer, Moss Carrie A
Jul/Aug 2020 Pg. 296-297	Finally: A Final U.S. Food and Drug Administration Memorandum of Understanding, but It's Flawed Author(s): Brunner Scott
Mar/Apr 2017 Pg. 95-102	U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies Author(s): Yoch Doug
Sep/Oct 2017 Pg. 364-370	Child-safety Containers/Devices and Compounding Author(s): Allen Loyd V Jr