DNA and host cell protein impurities, routine testing versus validation studies - Scientific guideline

With regards to host cell protein impurities this document has been superseded, refer to by the question "Host cell proteins testing, drug substance specification (3.2.S.3.2, 3.2.S.4.1, 3.2.S.4.5)".

With regards to host cell DNA impurities, this document is still valid (refer also to question “Process validation, removal of process related impurities, process related impurities testing (3.2.S.2.5, 3.2.P.3.5)".

Please find the questions referred to on this page:

Questions and answers for biological medicinal products

Document

Position statement on DNA and host cell proteins (HCP) impurities, routine testing versus validation studies - partly superseded

AdoptedReference Number: EMEA/CPMP/BWP/382/97