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INTEGRATED MANAGEMENT SYSTEM (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 a valid 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, as follows:

• A Pharmaceutical Quality System in PC Pharmaceuticals, which is based on cGMP requirements for production and control of safe, efficient and quality medicinal products for human use and on the international ISO 9001 and ISO 14001 standards, as well as ISO 13485 standard for medical devices and HACCP for food safety (food supplements);

• The System for Quality, Environment and Food Safety in PC Chemicals, Cosmetics, Botanicals – the Botanicals Program is based on the requirements of HACCP/General Principles of Food Hygiene (CAC/RCP 1-1969 Rev.4-2003) and HALAL for food safety, international ISO 9001 and ISO 14001, ISO 45001, FSSC 22000 (for teas)

• The system for organic production for the organic herbal products of Alkaloid AD Skopje - PC Chemicals Cosmetics Botanicals - Botanicals program, in accordance with the regulation (EC) No.834 / 2007 and (EC) No.889 / 2008, USDA-NOP, JAS

• The Quality System in PC Chemicals, Cosmetics, Botanicals – the Cosmetics Program is based on cGMP requirements (for drugs), 1223/2009/EC Directive for production of cosmetic products as well as the international ISO 14001 and ISO 45001 standards;

• The Quality System in PC Chemicals, Cosmetics, Botanicals – the Program Chemicals - Medical Devices is based on requirements of ISO 13485 and ISO 9001 standards, as well as the 93/42/EEC European Medical Devices Directive, 2007/47/EC Directive and applicable MEDDEV guidelines;

• The Quality System in PC Chemicals, Cosmetics, Botanicals – the Chemicals program is based on ISO 9001, ISO 14001 and ISO 45001 standards requirements;

• The pharmaceutical quality system in Alkaloid doo Belgrade, Alkaloid Veledrogerija doo Belgrade and Alkaloid CONS DOOEL, which is based on cGMP and the international ISO 9001 and ISO 14001 standards.

• Alkaloid's integrated management system unites all subsidiaries in the implementation of the company's corporate function.

The Integrated Management System is a documented system of a process model with functional value within the overall Alkaloid AD policy. The important documents are the Alkaloid’s Integrated Management System Policy, that is closely related to the vision and mission of the company, the IMS Manual, the Environmental Master Plan, procedures, standard operating procedures (SOPs), instructions and other documents. Keeping customers, business partners, employees and shareholders satisfied as well as continuously improving the IMS, is our objective.