The General Coordination of Accreditation (Cgcre) of the National Institute of Metrology, Quality and Technology (Inmetro) has launched a pilot program to establish national accreditation for biobanks in Brazil. Based on the requirements of the ABNT NBR ISO 20387:2020 standard (the Brazilian adoption of the international ISO 20387:2018 standard), this pilot program will serve to evaluate and refine the official accreditation model before it becomes permanently available in Inmetro’s portfolio.
Applications for the pilot program run from May 15 to June 30, 2026. Following the application phase, Cgcre will carry out on-site audits between August and December 2026, with the first official accreditations projected to be finalized by March 2027. This initiative represents a milestone for Brazil’s quality infrastructure, aligning local biotechnological and pharmaceutical research facilities with international best practices.
Defining a Biobank and the Scope of ISO 20387
Under ABNT NBR ISO 20387, a biobank is defined as a structured entity that performs the acquisition and storage of biological materials, alongside one or more related steps including the collection, preparation, preservation, testing, analysis, and distribution of biological specimens, as well as their associated clinical and demographic data.
The standard applies to all organizations handling human, animal, plant, and microbial biological materials destined for research, development, and biotechnological innovation. The accreditation framework does not cover biological materials intended for direct food/feed production or clinical diagnostic laboratories performing routine patient testing (which fall under ISO 15189).
Pilot Program Prerequisites and Technical Forms
Inmetro has emphasized that the pilot program is not a consulting or training project. To participate, biobanks must have already fully implemented the requirements of ABNT NBR ISO 20387:2020.
Applicants must submit their formal requests via email to acreditacao_biobanco@inmetro.gov.br before the June 30, 2026 deadline, attaching the following completed technical documentation:
- FOR-CGCRE-446: The checklist of documents required for requesting biobank accreditation or scope extension.
- FOR-CGCRE-450: The proposed scope of accreditation, detailing the specific biological materials and processes (e.g., human tissues, microbial strains, preservation methods).
- FOR-CGCRE-449: The technical scope definition form for ABNT NBR ISO 20387.
- MOD-CGCRE-001: The Accreditation Commitment Term (Termo de Compromisso de Acreditação – TCA), legally binding the organization to Inmetro’s audit rules.
Operational Roadmap for the Pilot Program
The development of the accreditation program is a coordinated effort between three internal divisions of Cgcre: the Division of Accreditation Program Development (Didac), the Division of Laboratory Accreditation (Dicla), and the Division of Accreditation Training (Dicap).
The scheduled timeline for the pilot is as follows:
| Activity | Start Date | End Date |
|---|---|---|
| Application Period | 2026-05-15 | 2026-06-30 |
| Completeness Check | 2026-07-01 | 2026-07-15 |
| Audit Scheduling | 2026-07-16 | 2026-07-31 |
| On-site Audits | 2026-08-01 | 2026-12-31 |
| Accreditation Decisions | 2027-01-01 | 2027-03-31 |
Regulatory Comparison: Brazil vs. United States and Europe
Implementing ISO 20387 ensures that biological samples preserved in Brazil are recognized as highly reliable internationally. The table below compares Brazil’s biobanking quality framework with the models used in the United States and Europe.
| Feature | Brazil (Inmetro / Cgcre) | United States (CAP BAP / NCI) | Europe (BBMRI-ERIC) |
|---|---|---|---|
| Primary Standard | ABNT NBR ISO 20387:2020 | ISO 20387 & CAP Biobank Accreditation Program Checklists | ISO 20387 & CEN/TS specifications |
| Accreditation Authority | Inmetro / Cgcre (Federal government) | College of American Pathologists (CAP) / Voluntary peer-review | National Accreditation Bodies (e.g., COFRAC, DAkkS) coordinating with BBMRI-ERIC |
| Scope of Materials | Human, Animal, Plant, and Microbial | Primarily Human (clinical and oncology-focused) | Human, Animal, and environmental bioresources |
| Government Involvement | Direct federal administration and licensing | Indirect; NIH/NCI provides guidelines, CAP manages audits | Structured European Research Infrastructure Consortium (ERIC) |
Compliance Directives for Research Centers and Biotechnology Firms
Biotechnology companies, clinical trial sponsors, and academic research institutions operating biobanks in Brazil should adopt the following directives:
- Execute a Mock Audit: Conduct a internal audit against the ABNT NBR ISO 20387:2020 clauses, focusing on sample collection consent records, storage temperature telemetry, chain of custody logs, and data protection policies.
- Compile the Application Dossier: If your facility meets the criteria, download forms FOR-CGCRE-446, 449, 450, and MOD-CGCRE-001 from the Inmetro portal. Map the exact categories of biological specimens stored on-site and submit the dossier before June 30, 2026.
- Establish Sample Integrity Benchmarks: Implement standard operating procedures (SOPs) defining quality control limits for sample viability and DNA/RNA integrity, which will be heavily scrutinized by Cgcre auditors during on-site evaluations.
- Harmonize with LGPD Guidelines: Ensure that all demographic and genetic data associated with biological samples comply with Brazil’s General Data Protection Law (LGPD), establishing strict access controls and patient anonymization workflows.
Source: Inmetro Press Release – Inmetro lança programa de acreditação de biobancos no Brasil