On its 25th anniversary, GM PHARMA is starting with a significant milestone – the company has successfully passed the inspection of the Medical and Pharmaceutical Activities Regulation Agency and has been awarded, for the second time, the Georgian National Good Manufacturing Practice (GMP) compliance certificate.
Since January 1, 2022, an amendment to the Georgian law “On Medicines and Pharmaceutical Activities” has come into effect, making GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certification mandatory for pharmaceutical product manufacturers and wholesale distributors. The recertification process takes place every three years, which GM PHARMA has successfully completed.
It is noteworthy that GM PHARMA’s solid dosage forms manufacturing site in Tbilisi, Georgia, is the largest pharmaceutical plant in the South Caucasus region and the only facility where a full production cycle of oral solid dosage forms is carried out. The full production cycle encompasses the entire process, from sourcing raw materials to the release of the final product, including dispensing, blending, granulation, tableting, tablet coating, capsule filling, bottle filling, sachet filling and blister and bottle packaging, quality control.
As the company states, the GMP certificate obtained in 2022 was not a novelty, as GM PHARMA had already been awarded the Good Manufacturing Practice (GMP) EU Vol. IV compliance certificate back in 2007 by the Heathside Information Services, United Kingdom.
Currently, the company holds all national and international certificates, permits and licenses required for pharmaceutical manufacturing: Good Manufacturing Practice – National GMP (Georgia, from 2022 year); Good Manufacturing Practice – GMP PIC/S (International, from 2014 year); 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.
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.
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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