Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment: Part 1

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.