Quality Management
System
NTC ANDAR Quality Policy: Quality Risk Management, GDP certification and formal qualification of every active substance supplier.
Quality Management System
- The Quality Policy covers the activities of NTC ANDAR Sp. z o. o. in the import and distribution of active pharmaceutical substances for human and veterinary medicinal products, as well as other starting materials and production raw materials for the pharmaceutical, food, cosmetics and veterinary industries and related sectors.
- The Quality Policy is implemented through the development, operation and supervision of the company’s Quality Management System (QMS), which structures existing processes and ensures that product safety and the required quality are maintained.
- The QMS is based on the principles of EN ISO 9001:2015. It is documented, implemented, audited and continually improved. It covers the activities needed to ensure that import, storage, distribution, transport and order fulfilment processes meet legal requirements and the expected quantitative and qualitative requirements.
- In particular, the QMS ensures that the Company fully meets the requirements of Pharmaceutical Law, Good Manufacturing Practice and Good Distribution Practice for Active Substances used as starting materials for medicinal products, and Good Distribution Practice for active substances used as starting materials in veterinary medicinal products.
Oversight policy
- The documentation system is used to establish, control, monitor and record activities that directly or indirectly affect all aspects of quality.
- The Company collects and keeps documentation that allows supply chains to be traced, providing full traceability of transport, storage and environmental conditions (where applicable) for the imported or distributed material at every stage of order fulfilment, in line with the established distribution route monitoring procedure.
- API quality assurance is delivered through a deviation management system and change control. Where appropriate, corrective and preventive actions are taken.
- Our complaints procedures and procedures for non-conforming substances set out in detail how to proceed and who is responsible. Complaints and investigations are documented and handled effectively.
- Providers of key services and suppliers of active pharmaceutical substances are subject to qualification.
- All areas of the Company’s activity covered by the quality assurance system are regularly reviewed and audited.
Qualified staff
- All employees have the appropriate qualifications and professional experience, receive ongoing training and are committed to quality. Every employee is responsible for carrying out the tasks arising from this Quality Policy within the scope of their duties.
- The organisational structure designates a member of senior management responsible for coordinating the oversight of the quality management system, who is responsible for organising Quality Management and supervising the implementation and operation of the system in line with applicable law.
The Management Board bears full responsibility for implementing this Quality Policy and ensures that it is understood by all employees, implemented and monitored, and consistent with the Company’s strategic objectives.
Three things
we check constantly
The goals of our Quality Policy shape our daily work: every delivery can be traced, every process has a written procedure, and the system is reviewed regularly.
Certificates and authorisations
Pursuant to Article 51b of the Polish Pharmaceutical Law of 6 September 2001, our company is entered in the National Register of Manufacturers, Importers and Distributors of Active Substances intended for the manufacture of medicinal products and, pursuant to Article 111(6) of Directive 2001/83/EC and Article 80(6) of Directive 2001/82/EC, in the European EudraGMDP database.
We hold a GDP certificate and are authorised to trade in products of animal origin and category 3 animal by-products intended for use, among others, in the manufacture of medicinal products, medical devices, cosmetics and veterinary products.
