International pharmaceutical company GM PHARMA hosted a GMP inspection conducted by the regulatory authority of the Republic of Azerbaijan. The inspection was carried out at the company’s state-of-the-art manufacturing facility in full compliance with European Union Good Manufacturing Practice (EU GMP) requirements.

The GMP inspection conducted by the Azerbaijani regulatory authority marks another significant milestone in the advancement of GM PHARMA’s international expansion strategy and continuous enhancement of its quality management systems. The upcoming export of pharmaceutical products to the Republic of Azerbaijan represents not only entry into a strategically important market, but also further international recognition of GM PHARMA’s state-of-the-art manufacturing capabilities, robust quality systems, operational excellence, and full compliance with global pharmaceutical standards.

The inspection was led by representatives of the Analytical Expertise Center under the Ministry of Health of the Republic of Azerbaijan - Hamid Gurbanov, Head of the GMP Department, and Said Farzullayev, Head of the Pharmaceutical Track and Trace Department.

The primary objective of the inspection was to assess the compliance of the company’s quality systems, manufacturing processes, infrastructure, and operational procedures with international GMP standards, once again highlighting GM PHARMA’s strong commitment to quality, patient safety and regulatory excellence.

During the inspection, the regulatory authority comprehensively evaluated the company’s Quality Management System (QMS), manufacturing operations, production areas, equipment, documentation systems, personnel qualifications, sanitary and technical conditions, validation activities, change control procedures, outsourced operations, quality control processes, complaint handling systems, self-inspection procedures, deviation management, and CAPA systems (Corrective and Preventive Actions).

The key purpose of the inspection was to confirm that pharmaceutical products are manufactured under controlled conditions, that the quality system functions effectively, and that products delivered to patients are safe, effective, and consistently meet international GMP standards.

The inspection was conducted in several stages and included both detailed facility walkthroughs and an extensive review of documentation. Particular attention was paid to production areas, quality control laboratories, HVAC systems (Heating, Ventilation and Air Conditioning), water systems, personnel training, validation activities and change management processes.

For GM PHARMA, this inspection represents another significant step forward in strengthening international partnerships and continuously enhancing the company’s quality management systems. Inspections of this scale contribute to reinforcing operational excellence and increasing trust across international pharmaceutical markets.

The visit of the Azerbaijani regulatory authority serves as an important sign of international recognition and confidence in GM PHARMA. Such inspections support broader access to international markets, strengthen corporate reputation, ensure continuous quality improvement, and foster effective collaboration with global regulatory authorities.

Good Manufacturing Practice (GMP) remains the fundamental international quality standard for pharmaceutical manufacturing, ensuring that medicinal products are consistently produced and controlled according to stringent quality requirements.

GM PHARMA continues to maintain full compliance with international GMP requirements while manufacturing high-quality pharmaceutical products for both local and international markets.

It is worth noting that GM PHARMA’s manufacturing facility in Tbilisi is one of the leading pharmaceutical production sites in the Caucasus region and operates a full technological cycle for the manufacturing of solid dosage forms. This full-cycle manufacturing process includes every stage - from raw material sourcing to final product release - including dispensing, blending, granulation, tableting, encapsulation, coating, packaging and quality control.

The company possesses all major national and international certifications and authorizations required for pharmaceutical manufacturing, including the Georgian National GMP Certificate, international PIC/S and EAEU GMP certificates, ISO 9001:2017, ISO 17025 and other internationally recognized certifications.

Since its foundation, GM PHARMA’s mission and values have remained unchanged - to continuously improve product quality through scientific approaches and industry best practices, and to develop and deliver pharmaceutical products that improve patients’ quality of life and contribute to longer, healthier lives.

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