The Company has implemented and operates an effective Quality Management System consisting of Quality Assurance and Quality Control units. The Quality System is set up according to current Good Manufacturing Practice (cGMP) and complies with the expectations of both national and international (EU) regulatory agencies.
The Company’s quality policy is based on the principles laid down in the Quality Manual. The products are manufactured in accordance with requirements of the relevant marketing authorizations (MAs) ensuring consistent quality, purity, safety and efficacy.

The Quality Assurance unit is functioning independently of Production to ensure that:

• the design, development and manufacture of the Company's medicinal products is carried out in accordance with current GMP and cGLP regulations
• the active and inactive pharmaceutical ingredients, packaging materials used in production are exclusively of compendial (Ph. Eur) grade. The sourcing of materials is controlled through approved suppliers.
• products are manufactured and tested according to marketing authorization requirements
• personnel engaged in manufacture or quality control of product are appropriately trained
• equipments used are qualified, the manufacturing and analytical processes are validated
• finished products are released under strict control following the rules set forth by regulatory agencies
• finished products are handled, stored and shipped under appropriate conditions that protect quality during the expiry period.

The efficiency and performance of the Quality Management System is controlled regularly by self inspections. The Management Team of ExtractumPharma Rt. is committed to adhere to the principles of the Quality policy and expects its employees to act in accordance with these rules in all phase of their day to day activities.

The ExtractumPharma Rt., as a company carries a dual responsibility on one hand, our medicinal products manufactured should fulfill the expectations of patients and physicians, and on the other hand our business pursuits should strictly follow the current standards and legislation requirements of the pharmaceutical industry. This challenge, however, combined with our high sense of responsibility and motivation, fuels our efforts toward continuous future improvements.

Related link

GMP certificate