Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

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

Issue:  Sep/Oct 2021 - Volume 25, Number 5
View All Articles in Issue

Page(s):  389-395

Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 1
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 2
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 3
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 4
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 5
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 6
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2 Page 7

Download in electronic PDF format for $75

Abstract:  Container-closure integrity provides assurance that compounded sterile preparation quality attributes are met throughout its shelf life. Since compounded sterile preparations lacking container-closure integrity are considered adulterated as per the Federal Food, Drug and Cosmetic Act and are therefore unsafe for patient use, compounders must be able to produce a well closed sealed vial. Furthermore, 503B outsourcing facilities must qualify the capping process as described by the proposed “Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act Guidance for Industry.” This article is the second in a series describing vial crimping and capping equipment selection and the qualification necessary to create a well-closed sealed vial in a Current Good Manufacturing Practice environment to ensure patient safety and maintain compliance.

Related Keywords: Doral (Neal) O. Higgins, Melanie J. Prudom, MBA, Amy Summers, PharmD, BCSCP, container-closure integrity, container-closure system, U.S. Food, Drug and Cosmetic Act, vial sealing, compounded sterile preparations, capper devices, crimper devices, vial-capping qualification process, installation qualification, operational qualification, performance qualification, drug safety

Related Categories: LEGAL, PACKAGING, STERILE PREPARATIONS, QUALITY CONTROL

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 1
Higgins Doral (Neal) O
, Prudom Melanie J, Summers Amy
Jul/Aug 2021
Pg. 298-302

Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 2
Higgins Doral (Neal) O
, Prudom Melanie J, Summers Amy
Sep/Oct 2021
Pg. 389-395

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
Pg. 454-461

Basics of Sterile Compounding: Intravenous Admixture Preparation Considerations, Part 10: Packaging and Container-closure Issues
Allen Loyd V Jr
Jul/Aug 2021
Pg. 311-317

How to Qualify Container Closure Systems for Intended Use, Part 2: Choosing the Right Components for Container Closure Systems
Vaughn Stacey R
, Radwick Allison
Jan/Feb 2020
Pg. 14-19

A Review of Parenteral Admixtures Requiring Select Containers and Administration Sets
Rice Stephen P
Mar/Apr 2002
Pg. 120-122

Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines
Allen Loyd V Jr
Jul/Aug 2016
Pg. 351

View Sample
Evaluation of the Efficacy and Superiority of Different Vial Rubber Closure Disinfection Techniques
Bjornstad Matthew
, Kosinski Tracy, Burlage Robert
Sep/Oct 2020
Pg. 434-438

Choosing a Vial Processing Line for Aseptic Compounding: Part 1
Noorian Shaun
, Vahedi Navid
Jul/Aug 2016
Pg. 283-292

U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances
Miller David G
Jul/Aug 2015
Pg. 303-305

PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs
Allen Loyd V Jr
Sep/Oct 2017
Pg. 356

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

U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs
Allen Loyd V Jr
Nov/Dec 2015
Pg. 487-488

In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers
Bhattacharya Sisir
, Parekh Satish, Dedhiya Mahendra
Sep/Oct 2015
Pg. 432-436

Standard Operating Procedure: U.S. Food and Drug Administration Inspection--Releasing a Sample to the U.S. Food and Drug Administration
Kupiec Tom
, Kemp Jesse
Jul/Aug 2007
Pg. 326-327

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

Finally: A Final U.S. Food and Drug Administration Memorandum of Understanding, but It's Flawed
Brunner Scott
Jul/Aug 2020
Pg. 296-297

Sterile Basics of Compounding: Contamination Control Strategies, Part 2
Summers Amy
Nov/Dec 2022
Pg. 497-504

Extending Practical (In Use) Shelf Life of Oncology Drug Vials Using Spikes
de Wilde Sofieke
, Crul Mirjam, Breukels Oscar
Mar/Apr 2023
Pg. 154-159

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
Pg. 377-380

Return to Top