Gothaplast = Quality production

  • GMP: QMS EURL 91/356
  • production facility certified by the Regional Monitoring Authority of Social Affairs and Health according to the German Drugs Law § 20 and pursuant to the rules of the WHO (World Health Organisation, New York) for the production of drugs and medical products, 'Good practices in the manufacture and quality control of drugs', i.e. the highest quality assessment standard according to the WHO
  • QMS Quality Management Standard, European Guideline, i.e. authorized production facility according to QMS, pursuant to the rules of the European Union on the manufacture of medical products, i.e. SOPs (Standard Operating Procedures), i.e. validated manufacturing instructions, validated testing rules, manufacturing reports, in-process controls
  • CE certified operation, i.e. manufacturing the products according to the harmonized European standards (Comité Européen)

The three above-mentioned certifications and rules for drugs and medical products are to be regarded as more stringent and more comprehensive than the ISO standards 9000 ff (ISO - International Organisation for Standardisation) normally applied to ordinary products for daily use

  • high manufacturing expertise thanks to experienced skilled workers 




© 2006 Gothaplast Verbandpflasterfabrik GmbH