-
Q5A - Q5E Quality of Biotechnological Products
Code Document Title Previously coded -
Finalised Guideline:
July 1997Description :The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.
Implementation ::Step 5
:EC, Europe - Adopted by CPMP, September 1997, issued as CPMP/ICH/294/95
:MHLW/PMDA, Japan - Adopted 14 July 2000, PMSB/ELD Notification No. 873
:FDA, US - Published in the Federal Register, 21 September 1998, Vol. 63, No. 182, p. 50244-9
:Health Canada, Canada - Implemented 5 January 2001, Catalogue No. H42-2/67-21-2000E
Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website
-