Pharmaceutical Packaging
Pharmaceutical Packaging

For the use of plastic materials in contact with pharmacologically active substances and medicinal products other regulations than those for the use of plastics in contact with food are applicable. In the European Union pharmaceutical packaging materials are regulated by the EU Pharmacopeia or by national Pharmacopeia and by the EMEA Guideline on Plastic Immediate Packaging Materials. In USA the US Pharmacopeia is applicable.

 

Services
  • Development of application strategy and test program for inclusion of a new substance (monomer or additive) in a Pharmacopeia
  • Compilation and submission of complete application dossier to competent authorities / regulatory body in Europe
  • Assessment of the safety of chemicals used in the manufacture of pharmaceutical packaging materials as well as of NIAS (Non Intentionally Added Substances)
  • Expert reports
  • Discussion with regulatory authorities and scientific bodies on client’s behalf
  • Compliance checks of products and ingredients
  • Advice on tests to be performed to check compliance (coordination and management of testing)
  • Literature search
  • Migration calculation