null Live Biotherapeutic Products (LBPs): unprecedented quality requirements by the Ph. Eur. Commission

EDQM Strasbourg, France 16/04/2018

At its 160th Session, the European Pharmacopoeia (Ph. Eur.) Commission achieved an important milestone in the setting of quality requirements for Live Biotherapeutic Products (LBPs) with the adoption of quality standards for LBPs for human use: a general monograph on Live biotherapeutic products for human use (3053), as well as two general chapters: Microbial examination of live biotherapeutic products (LBP): test for enumeration of microbial contaminants (2.6.36) and Microbiological examination of live biotherapeutic products: test for specified microorganism (2.6.38).

These three new texts will be published in Ph. Eur. Supplement 9.7 and will become effective in April 2019.