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Services

Range of activities

Laboratory of the Department of Sera and Vaccines Evaluation

  1. Serves as the national reference laboratory OMCL (Official Medicinal Control Laboratory) in the control research, immunological medicinal products, including vaccines and blood products. A European network of reference laboratories OMCL (European OMCL Network- GEON) (link to your contact list). A quality management system: is accredited by the Polish Centre for Accreditation (certificate AB509) and is subject to assessment by the members of the network OMCL- is accredited by the EDQM (EDQM certificate / MJA-100, the range of validation EDQM)
    2. His research quality of medicinal products and immunological blood as part of the initial batch control in order to confirm compliance with the specific requirements contained in the documents constituting the basis for issuing a marketing authorization and the requirements set out by the EDQM and the European Pharmacopoeia.
    3. conducts qualitative research biologicals.
    4. Prepares ruling initial batch control of medicinal products and immunological blood and the release of the initial batch control of medicinal products and immunological blood Certified OCABR
    5. Works with the Chief Pharmaceutical Inspectorate in the assessment of quality, safety and immunogenicity of immunological medicinal products and blood researching immunological medicinal products from the market, including products suspected of failure to meet quality requirements.
    6. conducts research development, validation and implementation of methods for biological, microbiological, serological, biochemical and molecular required in the control of immunological medicinal products, blood products and biologicals.

The necessary information related to the issuance of rulings initial batch control or exemption from the initial batch control immunological medicinal products and blood products are presented in the following links:

  1. Application Form No I-01/PO-03/LES/PKJ 2017.03.17
  2. I-02/PO-03/LES/PKJ ed. 07:2017.03.17 Application for batch release of immunological or blood-derived product (based on quality testing)
  3. I-05/PO-03/LES/PKJ ed. 02:2016.04.12 Application for administrative batch release of immunological or blood-derived product
  4. Price list of services

If you have questions, please contact the Unit of Records and Quality:
mgr Urszula Czajka
mgr Patrycja Szczodrak
Phone: +48 22 542 12 12
Fax: +48 22 54 21 311