Risk Assessment Tool for Excipients (RATE) has
been designed and validated by MPI. RATE is a tool designed to provide a platform to enable the recording of the risk assessments performed for excipients, in order to comply with the EU
The tool offers a mechanism for reviewing risks and scoring these in order to determine the overall risk level associated with the excipient and the manufacturer and the GMP control requirement.
Do you use multiple manufacturers of an excipient? Do you use excipients in different formulations? What if the excipient has different functions and volumes in the different formulations? RATE will help you to determine what approach should be taken where.
The RATE software will provide a structure to performing the following elements of the assessment process:
• Assessment of each of the excipients, from each manufacturer in each formulation, to ascertain the worst case use of each material on site against the criteria outlined in the guideline. This will create the Excipient Risk Profile.
• Assessment of each materials individual Excipient Risk Profile to determine the appropriate GMP that should be applied to its manufacture.
• Determination of the approach that will be taken to assessing the Excipient Manufacturers compliance to the required GMP.
• Assessment of the outcome of the compliance assessment to determine the overall Excipient Manufacturer’s risk profile against the criteria outlined in the guideline. This will create the Excipient Manufacturers Risk Profile.
For further information on McGee Pharma International’s Risk Assessment Tool for Excipients (RATE) and to request a demonstration, contact us at +353 1 846 47 42 or firstname.lastname@example.org.