ISO/GxP Industrial Facilities with In-House Biobanks to Pursue Accreditation for ISO 20387

Abstract

Introduction:

The International Organization for Standardization (ISO) standard 20387:2018 outlines general requirements for biobanks to ensure competence, impartiality, and uniform operation. Reasons for seeking ISO 20387 accreditation are improved compliance, international recognition, and increased credibility of a biobank.

Methods:

The Philip Morris International (PMI) BioBank is an in-house biobank of an ISO/GxP-driven, for-profit organization. A cross-functional team analyzed ISO 20387 requirements and assessed them against the existing quality management system (QMS) to identify gaps and develop a remediation plan. This allowed the development of an implementation plan with clear timelines. An audit room was reserved for the auditor and PMI BioBank representatives for the two-day audit. In the second room, a group of internal experts were available to answer the auditor’s questions, prepare solutions, and bring them to the audit room.

Results:

The gap analysis did not reveal any relevant deficits, given that the PMI BioBank follows the corporate QMS mainly based on ISO 17025. However, numerous checklist items require more specific adjustments to the existing QMS. Therefore, a corrective and preventive action (CAPA) was opened to demonstrate that gaps were identified and brought under control during the audit process. Four key areas required documentation employee competencies, complaint management, conduction of risk analysis, and impartiality maintenance. The audit lasted two days. One minor deviation was addressed with a detailed explanation of the process and was accepted by the auditor.

Conclusions:

Being part of an ISO/GxP-driven organization allowed the PMI BioBank to go through the ISO 20387 accreditation process rapidly. However, there was a noteworthy need for financial and manpower resources. Still, the benefits of demonstrating highly standardized processes are impactful as they enhance compliance and gain internal and external recognition, credibility, and reputation of an organization.