Accreditations, certificates

The accreditations of WESSLING Hungary Kft.

A management system has been in place at the Company since March 1996, and it has been developed into an integrated system extending to cover the complete organization in order to satisfy the requirements of system standards ISO 9001 and DIN EN ISO/IEC 17025, and also GMP guidelines required in drug manufacturing.

The quality policy of the Company is available here.

Environmental Testing Laboratory

According to the December 2015 decision of the Hungarian Accreditation Board (NAT), the Environmental Testing Laboratory of WESSLING Hungary Kft. is qualified as an independent testing laboratory under reg. no. NAT-1-1398/2015, which is valid until  07.12. 2019., its management system satisfies the requirements of standard DIN EN ISO/IEC 17025. Since NAT was one of the signatories of the mutual recognition agreement between the European co-operation for Accreditation (EA) and the International Laboratory Accreditation Cooperation (ILAC), accredited analytical results of the Laboratory are accepted not only in Hungary, but abroad as well.

Certificates

Food Testing Laboratory

The Food Testing Laboratory of WESSLING Hungary Kft. is accredited by the Hungarian Accreditation Board (NAT) under reg. no. NAT-1-1009/2015, which is valid until 01.12.2019., thus confirming the compliance of the management system of the laboratory with standard DIN EN ISO/IEC 17025. Since NAT was one of the signatories of the mutual recognition agreement between the European co-operation for Accreditation (EA) and the International Laboratory Accreditation Cooperation (ILAC), accredited analytical results of the Laboratory are accepted not only in Hungary, but abroad as well. Operation of the Laboratory is authorized by the National Food Chain Safety Office.

Certificates

Pharmaceutical Testing Laboratory, Batch Release Department

WESSLING Hungary Kft. possesses a manufacturer’s / importer’s authorisation for the quality control testing of human medicinal products and raw materials, and the batch release of final products. Compliance with GMP requirements was confirmed by the National Institute for Quality and Organizational Development in Healthcare and Medicine National Institute of Pharmacy. A manufacturer’s authorisation was obtained by the Laboratory and the Batch Release Department under reg. no. OGYI/17378-3/2013 for the quality control testing of medicinal products and raw materials, including testing and release of production batches of third country medicinal products. – The English language GMP certificate is available here.

GMP compliance was also confirmed by the Directorate of Veterinary Medicinal Products of NÉBIH. – The no. of the manufacturer’s authorisation issued by the Directorate for the quality control testing of veterinary medicinal products is MA-HU/17V/2006/M1.

Certificates

 

Environmental Consulting Business Unit and Food Safety Expert Group

Integrated management system of the Environmental Consulting Business Unit and the Food Safety Expert Group of our Company satisfies the requirements of standard MSZ EN ISO 9001:2009. Management system compliance of the business units was certified by TAM CERT Magyarország Vizsgáló és Tanúsító Kft. according to procedure TÜV Austria Cert. Reg. no. of the certificate is 20 100 131309913.

Certificates