Darnytsia Has Passed the Inspection of the Ministry of Health of Libya for Compliance With International GMP Standards And the Requirements of the Regulator of This Country
Darnytsia Pharmaceutical Company has successfully passed the inspection of the Ministry of Health of Libya and confirmed compliance with international Good Manufacturing Practice (GMP) standards and the requirements of the national regulator of this country.
Passing such an inspection is a mandatory condition for the further procedure of obtaining permission to export medicines to Libya.
Representatives of the Libyan delegation arrived in Ukraine to assess the production sites, quality assurance systems, documentation, and procedures of Darnytsia for compliance with GMP requirements.
In general, the inspection covered all key processes related to the production of medicines.
The inspection confirmed that all production processes of Darnytsia comply with international GMP standards, and therefore guarantee the quality and safety of the its products.
Obtaining the GMP certificate of Libya based on the results of the inspection will be the final step before entering the market of this country and expanding the geography of Darnytsia's exports.
"Entering new markets is a strategic priority for Darnytsia. Obtaining the GMP certificate of Libya is a pass to the market of this country. This opens up the opportunity for us to export medicines and provide local patients with quality medical products. Each new international recognition once again confirms the high level of our production standards and compliance with the strict requirements of regulators in various countries," says Hurhen Karapetian, Export and Hospital Sales Director at Darnytsia Pharmaceutical Company.
"Passing such an inspection is a very interesting experience for Darnytsia. After all, the regulatory requirements of Libya differ somewhat from Ukrainian and European ones. In particular, Libya's GMP includes requirements for personnel safety and handling pharmaceutical waste. Darnytsia proved its compliance with these requirements as well. This inspires us to move forward confidently," adds Olha Kramarenko, Quality Director at Darnytsia Pharmaceutical Company.