Acino receives EU GMP certification in Ukraine
Thursday 6th February 2020
Acino’s manufacturing plant in Ukraine—Pharma Start—has successfully been certified according to the Good Manufacturing Practice of the European Union (EU GMP) by the State Agency of Medicines of the Republic of Latvia.
Acino obtained a three-year certificate covering drug manufacturing (solid capsules, tablets), primary and secondary packing, and quality control (microbiological: nonsterile; chemical/physical). Acino’s new GDP certificate has been listed in the EudraGMDP database.
EU GMP is a mandatory standard for the certification of pharmaceutical production in Europe and is globally accepted. The GMP standard outlines the requirements for quality management systems, personnel management, equipment used, production facilities, and documentation.
‘The Swiss pharmaceutical group Acino values high standards of quality in all business processes, so the certification of production in accordance with the EU GMP standard is a significant and sought-after achievement,’ explained Eugene Zaika, Acino’s Regional Head Ukraine and CIS. ‘Ever since Pharma Start was acquired by Acino in 2015, we have been constantly improving our quality system and introducing innovative production technologies to ensure safety, efficiency, and consistently high product quality and manufacturing sustainability.’
‘Acino has invested over EUR 13 million in our manufacturing plant in Ukraine since 2015, focusing in production modernization, R&D, quality systems and energy-efficient solutions. The EU GMP certification demonstrates that Acino products manufactured in Ukraine meet the EU’s strict regulatory requirements and opens the door to new opportunities in markets across the world,’ added Zaika.
The EU GMP complements the GMP certification obtained in 2004 from the Ukrainian Authorities and the ISO 22000 Food Safety Management System certificate that Pharma Start received in 2018, which combines the requirements of ISO 9001 and HACCP for the development, production, quality control, sales, and transportation of dietary supplements.
Acino aspires to become a preferred brand for patients and healthcare professionals in emerging markets. Compliance with EU GMP requirements and ISO standards guarantees the high level of quality, efficiency, and safety of Acino products during development, manufacture, storage, distribution, and post-marketing activities.