Sponsor Audit: Biometrik’s Commitment to Quality and Compliance

Writer : Andi Darmawan

On September 10, 2025, PT Biometrik welcomed a sponsor audit at its laboratory facilities. One of the sponsors conducting the audit was PT Tropica Mas Pharmaceuticals, as part of their evaluation to ensure that the laboratory meets all regulatory requirements and international standards before being entrusted with conducting bioequivalence studies.

The audit was carried out over a full day and covered a wide range of critical aspects, including:

• Quality Management System, reviewing standard operating procedures (SOPs), documentation, and quality control workflows implemented within the laboratory.
• Regulatory Compliance, with particular focus on the application of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) principles to guarantee the reliability of study data.
• Facilities and Infrastructure, such as laboratory spaces, calibrated analytical instruments like LCMS/MS, sample storage systems, and environmental monitoring.
• Personnel Competency, assessed through interviews and examination of staff training records and professional experience.

Sponsor audit documentation at Biometrik

In addition to the document and facility review, the audit also served as an opportunity for open discussions between the sponsor and the Biometrik team. This exchange highlighted Biometrik’s transparency, readiness, and commitment to delivering trustworthy bioequivalence testing services.

Through this audit, PT Biometrik once again reaffirmed its commitment to maintaining quality, data integrity, and regulatory compliance. Earning the trust of sponsors is a vital foundation for sustaining growth and excellence in laboratory services, and Biometrik continues to uphold this trust by adhering to international standards in every stage of its operations.

Looking ahead, PT Biometrik is committed to further strengthening laboratory capacity, enhancing human resource competencies, and upgrading infrastructure in line with technological advancements. By doing so, Biometrik aims to remain the preferred partner for both national and international sponsors, contributing to the availability of medicines that are safe, effective, and of the highest quality for society.