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.
Annex II to Note for Guidance on Process Validation: - Non-Standard Processes (CPMP/QWP/2054/03)
Annex to the Note for Guidance on Process validation for Non-Standard Processes e.g. for specialised dosafe forms, non-standard sterilisation, new technologies.