According to the results of a routine inspection of production sites of finished pharmaceutical products and active pharmaceutical ingredients of SLC "InterChem", which was carried out in June of this year by specialists of the State Service of Ukraine on Medicines of the Ministry of Health of Ukraine, our company once again confirmed that its own production complies with the current Licensing Requirements. Also, as part of the inspection, the certification branch of the analytical laboratory, which monitors the quality of drugs at all stages of its production - from the final control of the raw materials used to the final products, was confirmed.
At the same time, if, as a result of the audit, the licensee was not criticized, he has reason to appeal to the State Service for the purpose of simultaneously confirming the compliance of the production with the requirements of good manufacturing practice (GMP). Thus, the InterChem SLC has confirmed for the fifth time that the production of finished pharmaceutical products of the company fully complies with GMP requirements. For the first time GMP certificate for finished medicinal products was obtained in 2007; In the future, the company confirmed its compliance with high standards of good manufacturing practice in 2009, 2011 and 2016.
A landmark event for InterChem was the receipt of a GMP certificate for the production of pharmaceutical substances (API). The creation of a new, up-to-date API production, which was completed in 2018, from the start of the project was carried out in full compliance with European good manufacturing practice requirements. The GMP certificate, first obtained in 2019, is a high assessment of the hard work of the entire team of the company.
The GMP certificate confirms the compliance of the production and pharmaceutical quality system with the EU GMP rules and PIC/S recommendations that operate in the field of trade and distribution in the country of direct production, as well as export.
GMP (Good Manufacturing Practice) - Good Manufacturing Practice is part of the concept of quality management that guarantees the production and control of pharmaceutical products according to quality standards that meet their requirements and the requirements of the registration dossier.