Balance between science and nature
over 90 years of tradition and science

ro / eng

Quality Management

The Quality management policy of Biofarm S.A. is to manufacture and market products that meet their designspecifications and are in accordance with the marketing authorisations/ notifications requirements, and at the same time generate no risks for the patients due to their lack of safety, quality and effectiveness.

The main objective of our quality management policy is to implement, certify, maintain and improve the quality management systemin compliance with the requirements of the international standard ISO 9001: 2000 and with the Good Manufactoring Practice (GMP) guideline.

The Quality Management Department operates in an efficient manner to ensure that all company activities are in compliance with the principles and procedures of the company quality management system. Its personnel is involved in equipment assesment and validation of activities, of changes control process, deviation investigation, implementation of preventive and corrective counteractions, internal and external auditing, quality complaints management, issuance of product series and product quality periodical review.

All the product series are issued by Qualified Individuals who are certifiedin accordance with UE Directives and Good Manufacturing Practices (GMP).