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Accreditation, certification and quality control


All GeneProof in vitro diagnostic kits are manufactured under the conditions complying with the quality control system requirements defined in the Council Directive No. 98/79/EC, annex VII, article 3.2 as specified in later regulations. Requirements of this Directive were adopted in the Czech Government Order No. 453/2004 Coll. Diagnostic kits for establishing the chlamydia and cytomegalovirus genomes are, according to the Directive, classified in the list B, Annex No. 2 and therefore their compliance was assessed by the Notified Body No. 1023 (Institute for Testing and Certification, Zlín, Czech Republic) according to the Annex No. 7 and the requirements of the ČSN EN ISO 13485:2003 standard. Other in vitro diagnostics are classified in the list D and therefore they are assessed according to the Annex No. 3.

The Company has a Quality Control Department headed by an experienced person with a 20-year experience in the field of molecular biology and genetics in accredited laboratories, owner of the Certificate of competence to act as a quality auditor for quality standards of the ISO 9000 and ISO 14000 range.

The Company prepares for acquiring certificates of good manufacturing practice according to the Notice of the Ministry of Health and Ministry of the Agriculture No. 411/2004 Coll. and the Directive No. 2003/94/EC and according to the requirements of the World Health Organization (WHO). Concurrently it prepares for acquiring laboratory accreditation according to the ČSN EN ISO/IEC 17025 and ČSN EN ISO 15189 standards. All development and manufacturing procedures are prepared in harmony with the recommendations of these standards and the laboratory activities proper are performed in harmony with them. There has been established a work environment and storage area control system for both base materials and final products. All employees are regularly trained for work in the good manufacturing practice system and they are subject to continual qualification improvements.

The manufacturing includes handling genetically modified organisms (GMO). A special laboratory was built within the Company premises for this purpose where the genetically modified organisms are processed when preparing the standards for in vitro diagnostic kits. The laboratory work is aimed at the genetic handling proper, resulting in the preparation of recombinant bacterial cells, their multiplication, storage and subsequent utilization for standard preparation. GMO handling in the Company is performed according to the Act No. 78/2004 Coll. as specified in the Act No. 346/2005 Coll. Notice of enclosed handling of genetically modified organisms, classified in hazard category 2, was approved by the Ministry of the Environment in the ministerial order No. 44424/ENV/07 dated August 16, 2007.

The Company takes care of recycling packaging materials from the purchased base materials and it participates in assuring returning and recycling of packaging waste organized by the EKO-KOM company under the identification number EK-F00041495. Disposal of potentially infectious waste is organized by an external supplier.