Another International Audit Successfully Completed at GM PHARMA, Further Strengthening Its Position in the European Market

Another International Audit Successfully Completed at GM PHARMA, Further Strengthening Its Position in the European Market

Another international audit has been successfully completed at GM PHARMA, an international pharmaceutical company, representing an important additional step toward strengthening the company’s position in the European market. The company’s state-of-the-art manufacturing plant was visited by the German consulting and auditing company Heacon Service GmbH pharma-audit (https://www.heacon.de/leistungen/pharma-audit) team, which conducted an assessment of compliance with European Union Good Manufacturing Practice (EU GMP) standards. The inspection once again confirmed that GM PHARMA’s production fully complies with EU GMP standards.

Heacon Service GmbH’s registered in Berlin, Germany, is a leading and highly reputable consulting and auditing company with extensive experience and strong expertise in the pharmaceutical and healthcare sectors. The company is recognized as one of Europe’s most trusted audit organizations and has maintained a high professional reputation for many years.

The Heacon team consists of highly qualified auditors with extensive international experience. The company’s lead-auditor Stefan Laconing and co-auditor Bernd Hasken, spent three days at GM PHARMA’s manufacturing plant, conducting a comprehensive EU GMP compliance audit.

Heacon Service GmbH’s lead-auditor, Stefan Laconing, provided a detailed overview of the inspection process. According to him, the audit was not limited to a superficial review; rather, it represented a thorough and multifaceted inspection of every stage of the manufacturing chain:

“As part of the audit, a full inspection of the manufacturing plant was carried out. Particular attention was paid to the main warehouses, production areas, chemical and microbiological laboratories, including the purified water system, wastewater management and supporting engineering systems.

Production and quality control documentation were assessed, along with the validation of analytical methods, technological and cleaning processes and the computerized systems used in quality control laboratories. The audit also covered equipment qualification, cleanroom concept qualification and monitoring, supplier and subcontractor qualification, personnel training and other key elements of the Quality Management System (QMS). Special attention was given to in-depth analysis of critical issues, as well as the identification of existing challenges and opportunities for improvement,” noted Stefan Laconing.

The results of the audit conducted by Heacon Service GmbH once again confirmed the full compliance of GM PHARMA’s quality management systems, manufacturing infrastructure and quality control processes, including microbiological and chemical laboratories, with EU GMP standards.

Representatives of GM PHARMA emphasizes that the successful completion of international audits represents one of the most important foundations for the continuous development of its quality management system and for expansion into international markets. According to Nino Rcheulishvili, Head of Quality Systems and Compliance at GM PHARMA, the visit of Heacon Service GmbH marks another significant milestone within the company’s strategy of continuous quality improvement.

“The visit of the auditing company Heacon Service GmbH represents an important step in GM PHARMA’s continuous quality improvement strategy and the audit results once again confirm the company’s full compliance with European and international pharmaceutical regulations.

GM PHARMA regularly undergoes EU GMP compliance audits and re-audits conducted by leading European consulting and auditing companies. Heacon Service GmbH is a German consulting and auditing company with a high professional reputation and it is important to note that GM PHARMA successfully passed an EU GMP compliance audit (EU GMP: EudraLex, Volume 4) back in 2023.

This audit confirms that through regular inspections we consistently and sustainably maintain processes implemented in accordance with regulatory requirements, clearly demonstrating our readiness to further strengthen our position in the European market,” noted Nino Rcheulishvili.

GM PHARMA continues to operate with a strong focus on quality, safety and international standards, forming a solid foundation for the company’s long-term development and market expansion. The company’s current strategic objective is to expand its business operations into Europe, Southeast Asia and South and Central America.

It should be noted that GM PHARMA’s manufacturing plant in Tbilisi is a leading pharmaceutical production plant in the South Caucasus region, featuring a complete technological cycle for the production of solid dosage forms. This full technological cycle covers the entire process from raw material sourcing to final product release, including dispensing, blending, granulation, tableting, tablet coating, capsule filling, packaging and quality control.

Medicines and biologically active food supplements produced by GM PHARMA are manufactured at GMP-certified plants located both in Western European countries (such as Germany, Spain, Switzerland and others) and at the company’s own GMP-certified manufacturing plant in Georgia.

The company holds all national and international certificates and permits required for pharmaceutical manufacturing, including Georgia’s national GMP certificate, international PIC/S GMP certificate, ISO 9001:2017, ISO 17025 and others.

Since its founding, the company’s mission and core values have remained unchanged - continuous improvement of quality and products based on scientific approaches and industry best practices and the manufacturing and supply of medicines that improve patients’ quality of life and help extend it.

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