Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use. This guideline supports implementation of a requirement in the Falsified Medicines Directive (FMD) that excipients be manufactured under appropriate GMP. It requires a formal risk assessment and specifies the criteria and attributes that should be considered and documented.
A copy of the proposal can be downloaded here: GDP consultation feb 2013