Quality Management System
The Quality Policy covers all activities of NTC ANDAR Sp. z o. o. related to the import and distribution of active pharmaceutical substances and other starting materials and production raw materials for the pharmaceutical, food, cosmetic, veterinary and related industries.
The Quality Policy is implemented by developing, implementing and supervising the company’s Quality Management System (QMS) and by Quality Risk Management (QRM), which structures the verification of existing processes and ensures the maintenance of product safety and their required quality.
The QMS is based on the assumptions of the EN ISO 9001:2015 standard. It is described, implemented, audited and continuously improved. It covers the activities necessary to ensure that the import, storage, distribution, transport and order execution processes meet the legal requirements and the expected quantity and quality requirements.
In particular, QMS and QRM guarantee that the Company fully meets the requirements of the Pharmaceutical Law, Good Manufacturing Practice and Good Distribution Practice for Active Substances Used as Starting Materials for the Manufacturing of Medicinal Products.
Supervision policy
Supervision policy
A documentation system is used to establish, control, monitor and record activities that directly or indirectly affect all aspects of quality.
The company collects and maintains documentation that allows tracking of all activities within supply chains in order to enable full traceability of transport, storage and environmental conditions (if applicable) in which the imported or distributed material or ingredient was at each stage of the order execution process in accordance with the established monitoring procedure of supply chain.
Quality assurance is carried out by the implemented system of supervision and tracking of all deviations from approved procedures and continuous control of changes. Corrective and preventive actions are taken where appropriate.
The applicable procedures for complaints and supervision over non-compliant substances describe in detail the procedure and responsibility in this regard. Complaints and explanatory proceedings are documented and effectively implemented.
Suppliers of key services and suppliers of active pharmaceutical substances are subject to qualification, audit and periodic assessment.
All areas of the Company’s operation covered by the quality assurance system are subject to regular reviews and audits.
Qualified personnel
All employees have appropriate qualifications and professional experience, undergo continuous training and are involved in quality assurance. Each employee is responsible for the performance of tasks resulting from this Quality Policy to the extent resulting from their duties at a given position.
In the organizational structure, there is a dedicated person from the top management responsible for coordinating work related to supervising the quality management system, who is responsible for organizing Quality Management and supervising the implementation and operation of the system in accordance with applicable law.
The Company’s Management Board is fully responsible for the implementation of this Quality Policy, which ensures that it is understandable to all employees, implemented and monitored, while maintaining its compliance with the Company’s strategic goals.
Certificates and licenses
Our company in accordance with art. 51b of the Act of September 6, 2001 – Pharmaceutical Law (Journal of Laws of 2020, item 944, as amended) is entered into the National Register of Manufacturers, Importers and Distributors of Active Substances intended for the manufacture of medicinal products and in accordance with art. 111 sec. 6 of Directive 2001/83/EC and Art. 80 sec. 6 of Directive 2001/82/EC is entered in the European database EudraGMDP.
We are GDP certified and authorized to trade products of animal origin and category 3 animal by-products intended for use, among others, in the process of manufacturing medicinal products, medical devices, cosmetic and veterinary products.
