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CERTIFICATES, STANDARDS AND AUDITS


NOW...

In views of the GMP standards for automated computerized systems (GAMP), improvements for all modules in AlkaSAP and upgrade of AlkaDMS for electronic control of processes and documents at a higher level are in a stage of implementation.

The humane, program-production orientation of Alkaloid, realized by applying the cutting-edge production technologies and business standards, is regularly confirmed with checks of the Integrated Management Systems of Alkaloid.

The production of quality, effective and safe drugs, by applying the principles of Good Manufacturing Practice (GMP), for which the trademark of ALKALOID AD Skopje is a symbol of a high level of safety, is confirmed by regular inspections by competent state inspection services from the Republic of Macedonia and abroad.

ALWAYS...

Permanent compliance to the standards, guidelines and directives, both as legal obligation and commitment to quality, safety and efficiency of all products of Alkaloid is all-pervading as it leads to our objective:

HEALTH ABOVE ALL.

IDENTIFICATION CERTIFICATION CARD

MALMED – GMP compliance certified

JAZMP – GMP compliance certified

MINPROMTORG - GMP compliance certified

SMDS - GMP compliance recognition

ISO 9001, ISO 14001, ISO 13485, ISO 45001 certified

FSSC 2000 certified

HACCP certified

HALAL certified

EU, JAS, USDA-NOP and NMK organic production certified

CE Certified

SUBSIDIARIES

ALKALOID KONS DOOEL, SKOPJE

• ISO 9001 certified.

• ISO 14001 certified.

ALKALOID D.О.О. BELGRADE, SERBIA

• ALIMS - GMP compliance certified.

• ISO 9001 certified.

• ISO 14001 certified.

ALKALOID WHOLESALES D.О.О. BELGRADE, SERBIA

• ISO 9001 certified.

• ISO 14001 certified.

ALKALOID-INT D.О.О. LJUBLJANA, SLOVENIA

• JAZMP - GMP compliance certified.

• JAZMP - GDP compliance certified

ALKA-LAB D.О.О. LJUBLJANA, SLOVENIA

• JAZMP - GMP compliance certified

ALKALOID D.О.О., ZAGREB, CROATIA

• Ministry of Health R.Croatia - GDP compliance certified

ALKALOID PHARM AG FRIBOURG, SWITZERLAND

• SwissMedic authorized

IMS Policy

The development and improvement of regulations, standards and guidelines resulted in integration and continuous improvement of the Integrated Management System (IMS). Alkaloid’s IMS is an important system of corporative and specific procedures and policies for Alkaloid’s AD head office and related subsidiaries/offices. The Integrated Management System consists of the systems of the profit centers i.e. programs/subsidiaries within Alkaloid.