The Next Step of GM PHARMA – EU GMP Certification
GM PHARMA, the only international, multinational pharmaceutical company from Georgia, is actively preparing for EU Good Manufacturing Practice (EU GMP) standards. This marks a significant milestone in the company’s growth and development, as well as in the evolution of Georgia's pharmaceutical industry.
As part of this strategic mission, GM PHARMA is partnering with the internationally renowned British consulting company Woodley BioReg, which stands out with 25 years of experience in pharmaceutical, biotechnology, and medical device regulatory affairs. The company regularly assists manufacturers in the UK, EU, South Asia, China, and South Korea in obtaining GMP certification and subsequently registering their products in highly regulated markets such as the European Union, the United Kingdom, and the United States.
The main goal of GM PHARMA, with the support of Woodley BioReg, is to become the first Georgian pharmaceutical company to officially obtain EU GMP certification. This achievement represents significant progress not only for the company but also for the entire pharmaceutical sector of Georgia. Ash Ramzan, the founder and principal consultant of Woodley BioReg, stated: 'It is a great honor for us to support GM PHARMA in achieving EU GMP standards. This significant step will help elevate Georgia’s pharmaceutical industry to a global level.''
As part of the certification preparation process, Woodley BioReg conducted another four-day intensive training/workshop at GM PHARMA. The topics of which included:2
- Corrective and Preventive Actions (CAPA),
- Supplier Management,
- Process Validation,
- Self-Inspection.
The training involved employees from GM PHARMA’s different departments, including representatives from Quality Systems and Compliance, Quality Control, Quality Assurance, Manufacturing, and Laboratories. It contributed to deepening knowledge about EU regulatory requirements and further strengthened the alignment of the company’s internal processes with EU GMP standards.
As Levan Varduashvili, CEO of GM PHARMA, stated: "Obtaining EU GMP certification is a crucial strategic step for our company, demonstrating our commitment to the highest quality standards. This certification will allow us to manufacture and supply medicines to the EU market, supporting our strategic growth and solidifying our position in the international pharmaceutical industry. The company’s aspiration is to transform from a regional leader in the pharmaceutical industry into a global organization.”
GM PHARMA's solid dosage forms manufacturing site in Tbilisi, Georgia, is the largest pharmaceutical plant in the Caucasus region. The basic formulation processes currently carried out in the factory are: dispensing, blending, granulation, tableting, tablet coating, capsule filling, bottle filling, sachet filling and blister and bottle packaging, quality control. Currently, the company holds all national and international certificates, permits and licenses required for pharmaceutical manufacturing: Good Manufacturing Practice – National GMP (Georgia); Good Manufacturing Practice – GMP PIC/S (International); Quality Management – ISO 9001:2015 and ISO 17025:2017/2018, etc.
Additionally, in 2023, GM PHARMA successfully completed the compliance audit for EU Good Manufacturing Practice standards (EU GMP: EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines), conducted by the highly reputable German company Heacon Service GmbH’s pharma-audit team. The Heacon group’s database includes information about the audit conducted at GM PHARMA, by which it was once again confirmed the compliance of the manufacturing site, laboratories, warehouse, equipment, utilities and quality management systems in general with the EU GMP standards.
It should also be noted that in 2024, a subsequent GMP inspection was conducted by the highly authoritative Ukrainian regulatory authority, based on which GM PHARMA was once again awarded the international GMP compliance certificate – PIC/S GMP. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors. It also aims to facilitate co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. Ukraine's regulatory authority joined the PIC/S alliance in 2011. As of today, only the Baltic states and Ukraine represent the Post-Soviet region in this organization, highlighting the high reputation of Ukraine's regulatory authority and the exceptional qualifications of its inspectors.
In 2024, GM PHARMA also successfully completed the GMP certification process conducted by regulatory authorities of Uzbekistan. It is noteworthy that significant reforms have been taking place in Uzbekistan's pharmaceutical industry over the past two years. As a result, the country's regulatory authority is planning to apply for PIC/S membership in the near future. This development further enhances the value of holding Uzbekistan’s GMP certificate.
All these achievements and compliance with international standards confirm GM PHARMA's readiness to enter the European Union market. The mission of GM PHARMA is to produce and supply healthcare products through a pioneering and innovative approach for the benefit of medicine and humanity by practicing all Quality and Safety norms and standards. The core value of the company is to touch and improve more patients’ lives with more GM PHARMA brands and products every day. Currently, more than 12 million patients are treated with GM PHARMA products in Georgia and the company's international, export markets every year, which shows the recognition of the company by consumers and healthcare specialists.
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