Audits in the Medicinal Products Sector

Ensure the highest standards of quality and regulatory compliance for medicinal products with GCB audits. Our audits offer an independent, expert assessment of production processes, infrastructure, and quality management systems – in line with GMP requirements, EU regulations, and international standards. We help manufacturers, suppliers, and subcontractors minimize risks, optimize processes, and strengthen brand trust.

The Importance of Audits in the Pharmaceutical Sector

Audits in the pharmaceutical industry are a key tool for verifying compliance with legal regulations, quality standards, and Good Manufacturing Practice (GMP) guidelines. Independent evaluations of manufacturing sites, suppliers, and subcontractors help identify non-compliance issues, implement corrective actions, and prevent potential threats to patient safety.

Comprehensive Audits Aligned with International Standards

GCB conducts comprehensive audits tailored to the specifics of the pharmaceutical industry, including:

Verification of compliance with GMP, GDP, and other standards (e.g., ISO, ICH, EMA, FDA),
Assessment of manufacturing facilities, laboratories, warehouses, and distribution centers,
Analysis of procedures, quality documentation, and risk management systems,
Identification of compliance gaps and proposals for corrective actions.

Audits can be carried out periodically (as part of a quality system), prior to product launch, during process changes, or in response to quality incidents.

Experienced Audit Team

Our auditors are experts with extensive experience in the pharmaceutical sector. Every audit is conducted with the utmost care, impartiality, and in accordance with the latest regulations. We work with both global pharmaceutical corporations and local manufacturers, adapting the scope of the audit to meet real operational needs.

Benefits of GCB Audits

Reduce the risk of product recalls and administrative penalties

Gain independent evaluations of suppliers and subcontractors

Increase operational efficiency and transparency in processes

Build trust with customers, business partners, and regulatory institutions

Maintain compliance with EU, FDA, WHO, and other regulatory authority requirements

Our Specializations

Our notified body, GCB, specializes in a wide range of certifications across various industries. With our experience and knowledge, we help companies worldwide ensure the highest quality and compliance of their products with EU and international market requirements.

Medical Devices

MedTech industry includes diagnostic equipment, surgical instruments, implants, imaging devices, health IT systems, in vitro diagnostic medical devices and more.

Find out more about medical devices

Medicinal Products

GCB supports pharmaceutical manufacturers through independent audits, documentation verification, and quality management system assessments. These services aim to confirm compliance with legal requirements and ensure the safety and efficacy of medicinal products introduced to the European and international markets.

Find out more about medicinal products