ALKALOID’S EU GOOD MANUFACTURING PRACTICE CERTIFICATES CONFIRMED

23.01.2020

ALKALOID’S EU GOOD MANUFACTURING PRACTICE CERTIFICATES CONFIRMED

Following the rendered inspection on behalf of the Public Agency of the Republic of Slovenia for Medicines and Medical Devices (JAZMP) carried out at the production facilities of Alkaloid AD Skopje, the certificates for compliance with the principles of Good Manufacturing Practice were confirmed. The same were renewed with validity of 3 years and pertain to the facilities for production of solid dosage forms (tablets and capsules), liquid dosage forms for internal and external use, semisolid dosage forms and the cephalosporins in accordance with the Directive 2003/94/EC and Article 111(4) from the Directive 2001/83/EC.

This regular audit and assessment of the Pharmaceutical Quality System of Alkaloid AD Skopje was carried out at all facilities simultaneously by the Slovenian Public Agency for Medicines and Medical Devices in the function of superintending authority. This type of audits rendered on behalf of high regulatory authorities are basis for obtaining and maintaining the endorsements for placement of Alkaloid’s products at the strictly and highly regulated markets of the European Union and similar.

The production of high quality, affordable, efficient and safe pharmaceutical products and consumer goods, where the logo of Alkaloid is a synonym for high level of quality and safety, as well as the human production program endeavors aimed primarily at the final consumers, shall remain guidelines in our everyday operations while closely observing the credibility and the professional approach we practice in our overall operations.