PT Biometrik Riset Indonesia Reinforces Commitment to National Standards Through BPOM Audit

Writer: dr. Ria Oktavia

Depok, November 24th 2025 – The Bioavailability and Bioequivalence (BA/BE) Center of PT Biometrik Riset Indonesia welcomed an audit by the Indonesian Food and Drug Authority (BPOM) as part of the regulatory assessment to ensure compliance with national standards for BA/BE study implementation.

The audit team from BPOM carried out a comprehensive review of the facilities, including laboratory operations, documentation systems, drug storage conditions, temperature monitoring, operational SOPs, and the conduct of both clinical and bioanalytical phases of the studies.

The audit proceeded smoothly with constructive communication between BPOM inspectors and the Biometrik team. Several findings were noted for improvement, particularly in documentation, procedural consistency, and completeness of records throughout the study processes. The findings were well received, and the Biometrik team has initiated Corrective and Preventive Actions (CAPA) to address each point and enhance overall quality compliance.

The Director of PT Biometrik Riset Indonesia, Ibu Effi Setiawati, expressed appreciation to BPOM for their guidance during the audit. “This audit is an essential step in reinforcing our commitment to maintaining research integrity and ensuring that all BA/BE studies are conducted in accordance with national regulatory standards. We remain committed to continuous quality improvement and to upholding the trust of our partners and study sponsors,” she said.

This audit serves as an important milestone for PT Biometrik Riset Indonesia in strengthening its quality management systems and ensuring the readiness of its facilities to support safe, accurate, and compliant BA/BE research activities.