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Certificates, Standards and Audits

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

The Alkaloid corporate symbol in blueMALMED – GMP compliance certified
The Alkaloid corporate symbol in blueFSSC 2000 certified
The Alkaloid corporate symbol in blueJAZMP – GMP compliance certified
The Alkaloid corporate symbol in blueHACCP certified
The Alkaloid corporate symbol in blueMINPROMTORG - GMP compliance certified
The Alkaloid corporate symbol in blueHALAL certified
The Alkaloid corporate symbol in blueSMDS - GMP compliance recognition
The Alkaloid corporate symbol in blueEU, JAS, USDA-NOP and NMK organic production certified
The Alkaloid corporate symbol in blueISO 9001, ISO 14001, ISO 13485, ISO 45001 certified
The Alkaloid corporate symbol in blueCE 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

Person selecting document icons on a digital interface

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.

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