News about GMP/cGMP

23.09.2022

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

The European Medicines Agency (EMA) plans to establish clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides. This week, EMA published new concept papers, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.


According to the agency, the proposed guidelines would address aspects of peptide and oligonucleotide manufacturing, characterisation, specification and analytical control “not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) and Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017).”


Source:

RAPS.org: Regulatory News

EMA: Concept Paper on Synthetic Peptides and Concept Paper on Synthetic Oligonucleotides


 

Comments