GM PHARMA – an international, multinational pharmaceutical company – has successfully passed another re-certification audit of the highly reputed Ukrainian regulatory authority and once again earned the international certificate of compliance with PIC/S GMP (Good Manufacturing Practice). It confirms that, manufacturing of solid dosage forms (tablets, capsules) at the company, the manufacturing site, laboratories, warehouse, equipment, utilities and quality management systems in general are in full compliance with the harmonized GMP standards of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), EU GMP regulations and World Health Organization (WHO) requirements.
PIC/S is an international co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human use. It aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors from PIC/S participating authorities. PIC/S is the best platform for facilitating co-operation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence. PIC/S was established in 1995 and presently comprises 56 Participating Authorities coming from all over the world (Europe, Africa, America, Asia and Australasia).
The regulatory authority of Ukraine joined the PIC/S in 2011. From the post-Soviet states, only Baltic countries and Ukraine are represented in PIC/S, which is a confirmation of the high reputation of the Ukrainian regulatory authority and the strong expertise of its inspectors.
GM PHARMA first received the international certificate for PIC/S GMP compliance back in 2014 and has since successfully passed the inspection for the 5th time.
For global regulatory authorities or healthcare providers, receiving a certificate for PIC/S GMP compliance is associated with the credibility and global image of a pharmaceutical company, high-quality pharmaceutical products, and reliable safety guarantees. Meanwhile, this certificate is an opportunity for pharmaceutical companies, including GM PHARMA, to register and introduce products in some member countries of PIC/S without additional GMP inspection, which will allow the company to spread its business to other geographical areas.
In addition to the PIC/S GMP certificate, GM PHARMA holds all national and other international certificates, permits and licenses required for pharmaceutical manufacturing, for example: the national GMP (Georgia) certificate, Quality Management Certificate – ISO 9001:2015 and ISO 17025:2017/2018, US Dietary Supplement Safety Inspection (NSF International) – NSF/ANSI. Likewise, GM PHARMA has successfully passed several important EU Good Manufacturing Practice (EU GMP) compliance audits conducted by the international consulting organisations:
2022 – PHARMACON (Denmark), a partner of the WHO.
2023 – Heacon Service GmbH, Pharma-Audit Group, Germany.
2023 – Woodley BioReg, United Kingdom.
The company's reputation as a leader in the pharmaceutical sector in Georgia and the Caucasus region is further reinforced by these audits, which attest to GM PHARMA's dedication to innovation and constant improvement.
With >140 brands and >230 dosage forms in its portfolio, GM PHARMA holds one of the broadest product portfolios in the region covering almost all dosage forms and therapeutic areas, including a wide range of food supplements. GM PHARMA exports more than 100 products globally and has representative offices in 7 countries.
GM PHARMA is focused on continuous growth and development. The company's future plans include investment in the latest technologies to expand manufacturing capacity to products like liquid ampoules and vials, lyophilized vials and oral liquids, to develop innovative dosage forms and products relevant to modern medicine, to enter the new pharmaceutical markets and to strengthen the focus on manufacturing and searching for the medicines that have no analogs in Georgian and export markets of GM PHARMA.
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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