The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
CPMP/QWP/2054/03 Annex II to Note for Guidance on Process Validation CHMP/QWP/848/99 and EMEA CVMP/598/99 Non-Standard Processes (Adopted by CHMP July 2004)
This Annex aims to set out what is understood by a "non-standard" manufacturing process and thereby to assist in the interpretation of the NfG on Process Validation.
