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 D.О.О., ZAGREB, CROATIA
- Ministry of Health R.Croatia - GDP compliance certified
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 PHARM AG FRIBOURG, SWITZERLAND
• SwissMedic authorized
IMS Policy