The Pharmaceutical Industry: Why Quality and Compliance Matter
The pharmaceutical industry involves the design, production, control, and distribution of medicines and therapeutic products. Medicinal products play a critical role in public health protection—they must be effective and, above all, safe. This demands strict regulatory compliance and continuous verification of processes and documentation.
Independent Verification of Medicinal Products
GCB offers third-party conformity assessments, which include:
- Verification of the product dossier – assessment of compliance with pharmaceutical legislation
- Auditing of manufacturing processes – in accordance with Good Manufacturing Practice (GMP)
- Evaluation of quality management systems – based on ISO standards and EU regulations
Our services help manufacturers minimize the risk of non-compliance, improve product quality, and enhance the chances of successful market authorization.
Audits for the Pharmaceutical Sector
We provide a range of audit services, including:
- GMP audits – evaluating compliance with Good Manufacturing Practices
- Third-party audits – independent evaluation of suppliers and subcontractors
- Documentation audits – assessing the completeness and accuracy of regulatory files
All audits are conducted by experienced GCB auditors, ensuring impartiality and objectivity. We provide a transparent assessment of regulatory compliance and identify areas for improvement.
Training and Competence Development
GCB also offers open training sessions and webinars for pharmaceutical professionals. These programs cover current regulations, GMP requirements, documentation standards, and audit procedures. Participants gain practical knowledge to help them prepare for inspections and implement regulatory expectations.
Why Choose GCB?
By partnering with GCB, you benefit from:
- Access to independent auditors experienced in the pharmaceutical sector
- Reliable verification of compliance with EU and international regulations
- Support in identifying risks and gaps in documentation or processes
- Shorter time-to-market through readiness for regulatory assessments
- Increased credibility and market position through independent evaluation
Our focus is strictly on regulatory conformity assessment—not operational consulting—ensuring the highest standards of safety and quality for medicinal products at every stage of their lifecycle.
