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 1

Author(s):  Higgins Doral (Neal) O, Prudom Melanie J, Summers Amy

Issue:  Jul/Aug 2021 - Volume 25, Number 4
View All Articles in Issue

Page(s):  298-302

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

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 first 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: container closure integrity, container-closure system, United States Pharmacopeia Chapter <1207>, package integrity evaluation, compounded sterile preparations, vial crimping, vial capping, vial sealing, vial closing, current good manufacturing practice, US Food and Drug Administration, FDA, capper, crimper, external contamination, 503B pharmacies, component supplier quality certification

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

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

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

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

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

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

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

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
Nov/Dec 2021
Pg. 491-496

Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2007
Pg. 404-410

Basics of Compounding: Implementing United States Pharmacopeia Chapter <1163> Quality Assurance in Pharmaceutical Compounding, Part 1
Allen Loyd V Jr
Mar/Apr 2012
Pg. 146-150

Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding--Nonsterile Preparations, Part 3
Allen Loyd V Jr
Nov/Dec 2011
Pg. 488-496

Basics of Sterile Compounding. 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 2
Martin Matt
Nov/Dec 2018
Pg. 475-478

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

Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding–Nonsterile Preparations, Part 4
Allen Loyd V Jr
Jan/Feb 2012
Pg. 64-68

Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations
Okeke Claudia C
Jul/Aug 2007
Pg. 302-305

Basics of Sterile Compounding: Sterile Product Packaging and Delivery Systems
Akers Michael J
Nov/Dec 2015
Pg. 491-500

Accuracy Considerations in Sterile Compounding
Akers Michael J
Mar/Apr 2017
Pg. 133-142

Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding--Nonsterile Preparations, Part 1
Allen Loyd V Jr
Jul/Aug 2011
Pg. 328-331

Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests
Kupiec Thomas C
Sep/Oct 2007
Pg. 400-403

Return to Top