Quality management

certyfikat zarządzanie jakością Wytwórnia Surowic i Szczepionek BIOMED Sp. z o.o. has been carrying out the policy of production of efficient, safe and high quality medicinal and medical products. The basic principle of the quality policy is care for patients’ health and Company’s authority based on the observance of the principles of GOOD MANUFACTURING PRACTICE (GMP) AND GOOD DISTRIBUTION PRACTICE (GDP). Based on these guidelines there has been developed and implemented the Quality Assurance System which is being constantly improved. Development, execution, implementation and systematic control of observance of the Quality Assurance System is dealt with by Quality Assurance System Department.

The developed and executed Quality Assurance System guarantees that:

  • the quality of medicinal and medical products is compliant with the requirements of the Specifications of Final Products,
  • the products are produced in repeatable manner, compliant with the process documentation,
  • are therapeutically efficient and safe for the patients,
  • the processes identified in the Company are understandable, analysed and there is connection between them.

In order to ensure the best quality of our products, the Quality Assurance Department controls if:

  • a product is designed and developed in accordance with GMP
  • production and control operations are clearly stated in the documentation
  • supplies of output and packing materials are provided by qualified suppliers
  • there are performed all necessary controls of intermediate products, process controls and validations as provided for in the established procedures
  • authorization of sale of medicinal products is only made by a Qualified Person certifying with the same that each batch was produced and inspected in accordance with the requirements of permit to trade the product and other quality documentation
  • storage, distribution conditions are compliant with the relevant regulations ensuring high quality of a product throughout its entire declared shelf life
  • the employees have got proper qualifications, are systematically trained and these actions are documented
  • the binding complaints and recall procedure is efficiently executed
  • there is a process of qualification and validation and if their changes are supervised.

In order to assess the efficiency and possibility to apply the Quality Assurance System in practice, the Quality Assurance System Department efficiently performs the procedure of internal and external audits, ensuring control of manufacturing conditions and high quality of output and packaging materials.
Applied procedures: risk analysis and annual review of the products allow for verification of the existing processes and maintaining the required quality of manufactured medicinal and medical products.

The executed quality policy and engagement and efforts of the staff have been rewarded with the certificate:

  • Integrated Management System PN-EN ISO 9001:2001 and PN-EN ISO 13485:2005 within the scope of: planning, production and sale of medicinal and medical products