Risk Assessment Tool for Excipients (RATE)

RATE

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 Guideline. 

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 info@mcgeepharma.com.

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Comments: 2
  • #1

    David Schoneker (Friday, 19 May 2017 16:06)

    Have you discussed this software with IPEC Europe? If not, I recommend that you do since IPEC Europe has published a specific guideline on how to do an appropriate risk assessment of excipients for the purpose of meeting the new EU requirements under the Falsified Medicines legislation. It would be a problem if the approach used in your software is not aligned with what IPEC Europe has published because most of industry intends to use the approach outlined by IPEC Europe which has been vetted with EMA.

  • #2

    McGeePharma (Tuesday, 23 May 2017 14:33)

    Thank you for your comment. Appropriate GMP is ascertained via GMP options in the program (options include: Vol 4 GMP Guideline Part 1 - Part 1 Annex 1; Part 1 Annex 2; Part 2, WHO Annex 5 / IPEC-PQC GMP excipients, etc.) as well as high level GMP elements as part of the risk assessment