Abstract

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

Page(s): 298-302

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  • 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

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

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