# Certificates, Standards and Audits

> An overview of the certificates and standards held by Alkaloid AD Skopje – GMP, GAMP and the regular audits of its manufacturing plants.

Source: https://alkaloid.com.mk/certificates-standards-audits

[Who We Are](https://alkaloid.com.mk/our-company)›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

[History of Certificates](https://alkaloid.com.mk/history-of-certificates)[Inspections and audits](https://alkaloid.com.mk/inspections-audits)

MALMED – GMP compliance certified

FSSC 2000 certified

JAZMP – GMP compliance certified

HACCP certified

MINPROMTORG - GMP compliance certified

HALAL certified

SMDS - GMP compliance recognition

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

ISO 9001, ISO 14001, ISO 13485, ISO 45001 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.

[Read more](https://alkaloid.com.mk/ims-policy)