The Parenteral Drug Association (PDA) and the International Pharmaceutical Excipients Council Federation (IPEC) as an outcome of its collaboration established in March 2018, announce the joint publication of a Technical Report for Formalized Risk Assessment for Excipients.
To comply with the European Commission Guidelines and PIC/S publication, excipients used in a drug product must be assessed for the risks that they pose to the drug product’s quality, safety, and purity. This requires drug manufacturers to ensure appropriate levels of GMP for excipients by using formalized risk assessments.
This joint PDA-IPEC Technical Report extends the PDA Technical Report No. 54 series on Quality Risk Management.
The Risk Assessment Technical Report is available:
IPEC Europe Members can download the Technical Report on the Member's Lab.
If you do not have access to the Member's Lab yet, please contact the Secretariat.