Abstract

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

Page(s): 389-395

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  • 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

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

  • 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

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