Quality & GMP 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 customized, high-touch support covers gap remediation, training and inspection rehearsal.

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 TMMDA 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 1, contamination control strategy (CCS) and quality risk management (QRM) expectations and data-integrity focus areas. Our scientist-led team performs targeted gap assessments, updates SOPs and provides training, and verifies that CMC documentation matches shop-floor reality.

On-Bir provides consultancy services for the planning and execution of technology transfer activities in accordance with international standards and national regulatory requirements. Our services cover gap analysis, development of the technology transfer strategy, preparation of transfer plans and protocols, transfer of manufacturing processes and analytical methods, process risk assessment, planning of validation activities, and preparation of technology transfer reports. We aim to ensure that technology transfers are completed effectively, traceably, and in alignment with the Pharmaceutical Quality System.

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.