Quality & Compliance

On-Bir prepares manufacturing sites for EU GMP certification with a scientist-led quality team that works directly on your systems, data integrity and shop-floor behaviours. Our personalised, high-touch support covers gap remediation, training and inspection rehearsal, coordinated with suppliers and partners across our regional distributor network.

On-Bir offers GMP compliance maintenance as a continuous service that keeps your quality system inspection-ready against EU GMP expectations year-round. Our scientist-led team stays close to deviations, data integrity and supplier changes that actually trigger findings.

On-Bir conducts GMP mock audits that simulate EU and Turkish authority interviews, facility walkthroughs and data requests under real inspection pressure. Unlike audit boutiques that stop at observations, our scientist-led team turns results into CAPA-ready actions, technical fixes and targeted coaching.

On-Bir supports international manufacturers seeking Turkish GMP approval by translating TİTCK/TMMAD expectations into a clear pathway for foreign-site inspections and imported product supply. Our scientist-led team combines Turkish and EU-GMP expertise with supplier audits, dossier alignment and on-site readiness work.

On-Bir provides GMP troubleshooting for sites dealing with recurring deviations, critical observations or stalled CAPA closure, focusing on root causes rather than cosmetic fixes. Our scientist-led team links investigations to process control, analytical methods, validation status and batch documentation.

On-Bir helps manufacturers adapt GMP systems to regulation updates such as EU GMP Annex changes (Annex I), contamination control strategy (CCS) expectations and data-integrity focus areas. Our scientist-led team performs targeted gap assessments, updates SOPs and training, and verifies that CMC documentation matches shop-floor reality.

On-Bir performs supplier audits and provides structured supplier audit reports that procurement teams, QPs and MAHs can use for qualification and re-qualification decisions. Our scientist-led approach adds EU-GMP and regulatory context plus remediation planning, delivering end-to-end assurance from audit planning to CAPA follow-up and ongoing compliance.