New quality requirements for sourcing chemical precursors for preparing radiopharmaceuticals

The European Pharmacopoeia Commission has adopted new quality requirements for sourcing chemical precursors for preparing radiopharmaceuticals. The new standards are one of six new entries approved for the European Pharmacopoeia set of manufacturing guidance by the Commission on 16-17 June at a meeting in Strasbourg, France.

The Commission also, for instance, approved new guidelines on testing for bacterial endotoxins, notably explaining how to conduct risk assessments when using a bacterial endotoxin test as a pyrogenicity test, because of potential contamination by non-endotoxin pyrogens.

The Commission also revised its advice on the potentiometric determination of pH and residual solvents. Meanwhile, it recommended using a new monocyte-activation test to avoid experiments on live animals. All this new guidance will come into force on 1 July.

The meeting heard from the Council of Europe’s Director General of Democracy, Snežana Samardžić-Marković, who welcomed the Commission’s April completion of its first finished product monograph, on sitagliptin tablets (usually guidance is for categories of medicines), its elaboration of a pan-European paediatric formulary and its work on the International Organisation for Standardisation’s (ISO) latest certification for pharmacopoeial activities.

'The Commission is clearly committed to propelling the European Pharmacopeia into a new era,' she said.

The Commission next meets on 17-18 November.