ISO/GxP Industrial Facilities with In-House Biobanks to Pursue Accreditation for ISO 20387
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Summary
This summary is machine-generated.The Philip Morris International BioBank rapidly achieved ISO 20387 accreditation by leveraging its existing quality management system. This process enhanced compliance and credibility, despite requiring significant resources.
Area Of Science
- Biotechnology and Biobanking
- Quality Management Systems
- Regulatory Compliance
Background
- The International Organization for Standardization (ISO) 20387:2018 standard provides requirements for biobank competence, impartiality, and operational uniformity.
- ISO 20387 accreditation offers benefits such as improved compliance, international recognition, and enhanced biobank credibility.
Purpose Of The Study
- To assess the Philip Morris International (PMI) BioBank's readiness for ISO 20387 accreditation.
- To identify and address any gaps within the existing quality management system (QMS) relative to ISO 20387 requirements.
Main Methods
- A cross-functional team conducted a gap analysis comparing ISO 20387 requirements with the PMI BioBank's current QMS, which is largely based on ISO 17025.
- A remediation plan and implementation strategy were developed, including a two-day audit with dedicated rooms for auditors and internal experts.
Main Results
- The gap analysis revealed minimal deficits, but identified specific areas needing QMS adjustments, including employee competencies, complaint management, risk analysis, and impartiality.
- A corrective and preventive action (CAPA) was initiated to manage identified gaps. One minor deviation was resolved and accepted by the auditor.
Conclusions
- The PMI BioBank's integration within an ISO/GxP-driven organization facilitated a swift accreditation process.
- Achieving ISO 20387 accreditation significantly enhances compliance, internal/external recognition, credibility, and reputation, though it necessitates substantial financial and personnel investment.
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