PDA TR 54-6

PDA Technical Report No. 54-6, Risk Assessment for Excipients, is the sixth technical report (TR) in the TR 54 series related to various aspects of Quality Risk Management (QRM). It was developed to provide additional guidance on the excipient risk assessment process required by the European Commission Guidelines on the formalized risk assessment for ascertaining the appropriate GMP for excipients of medicinal products for human use and incorporated into the PIC/S publication of the same name. The information in TR 54-6 applies to all excipients used in drug products for human use at all stages of the product lifecycle.