GM PHARMA Successfully Completes International GMP Audit Conducted by German Auditing Company Heacon Service GmbH
GM PHARMA, an international pharmaceutical company, has successfully completed another Good Manufacturing Practice (GMP) audit conducted by the German auditing company Heacon Service GmbH. The Mock GMP audit, designed to assess compliance with European Union Good Manufacturing Practice (EU GMP) requirements, concluded with a positive assessment.
The audit represented an important preparatory milestone ahead of the official EU GMP inspection planned by the German regulatory authority. It was also closely aligned with the company's strategic objective of registering a new pharmaceutical product in the European market.
The three-day audit was led by international experts Dr. Stefan Lakonig (Lead Auditor) and Dr. Jens Flemming (Co-Auditor).
During the audit, the experts conducted a comprehensive assessment of the company's Pharmaceutical Quality System (PQS), manufacturing infrastructure, technological processes, quality assurance and quality control activities, documentation, and pharmaceutical manufacturing management practices.
Particular emphasis was placed on the effectiveness of the Pharmaceutical Quality System and itsს compliance with EU GMP requirements. The assessment covered key quality management processes, including deviation management, Corrective and Preventive Actions (CAPA), Change Control, Quality Risk Management, document and record management, personnel training, self-inspection, and supplier qualification systems. The auditors also examined the interconnections between these quality systems, their practical implementation, and the mechanisms supporting continuous quality improvement.
A significant part of the audit focused on the entire lifecycle of pharmaceutical product development, manufacturing scale-up, Technology Transfer, and Process Validation. The experts assessed the transition from product development to commercial-scale manufacturing, mechanisms for transferring and implementing manufacturing technologies, approaches to manufacturing process control and validation, and the management of associated documentation.
In the laboratory area, particular attention was given to Analytical Method Validation, Analytical Method Transfer, and the implementation of analytical methods within the Quality Control Laboratory. The assessment examined mechanisms for ensuring the reliability and suitability of analytical methods, laboratory process documentation, and compliance with Data Integrity requirements.
In addition, the audit included a detailed review of manufacturing operations, equipment and system qualification, validation management, the integration of manufacturing and laboratory activities, and the practical implementation of EU GMP requirements.
GM PHARMA's modern pharmaceutical manufacturing facility, located in Tbilisi, Georgia, encompasses the full technological cycle for the production of solid dosage forms. The company continuously invests in expanding its manufacturing capabilities, implementing advanced technologies, and strengthening its quality management system through ongoing improvement.
The successful completion of this international preparatory GMP audit marks another significant step forward for GM PHARMA, both in strengthening its alignment with European regulatory requirements and in advancing its international development strategy.
GM PHARMA remains committed to implementing and continuously improving high quality standards, laying a strong foundation for the company's continued growth and expansion into the European pharmaceutical market.
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