SMARTRISK – risk assessment excipient tool


As Quality Risk Management is a fundamental component of current Good Manufacturing Practice (cGMP), it is no surprise that there is much regulatory emphasis on risk-assessments during any regulatory inspection. The expectation is that Quality Risk Management is embedded in the company’s Pharmaceutical Quality System (EudraLex Volume 4, Chapter 1 “Pharmaceutical Quality System”) [1]

In relation to the final dosage form of a medicinal product, the EU Directive on Falsified Medicines (2011/62/EU) [2] sets out a requirement for pharmaceutical manufacturers to carry out a risk-assessment for excipients used in medicinal products to determine the appropriate level of GMP applied during their production. Directive 2001/83/EC Article 46f [3] describes that the manufacturing authorization holder is required to ensure that the excipients are suitable for use in medicinal products.

This focus on excipient quality led to the publication of the EU Guidelines on risk assessment for excipients (2015/C 95/02) [4] effective since 21 March 2016. The excipient risk assessment procedure should be incorporated in the pharmaceutical quality system of the Manufacturing Authorization Holder.

The EU guideline provides an overview of the required risk assessment approach and includes areas for consideration for the application of Quality Risk Management principles to determine the inherent risk associated with an excipient and its impact on the quality, safety and efficacy of the medicinal product. The guideline focuses on the source of the excipient and its function in the final formulation.

The quality and validity of an excipient risk assessment is dependent on the knowledge and information the company has gathered about:

  • The excipient
  • Function and application of the excipient in its formulation
  • The manufacturer of the excipient

Excipient Risk Assessment must ensure that this information is used to assess excipient risk in 3 phases;

  • The inherent risk of the excipient based on its source (animal derived etc.) and its quantity and function within the medicinal product formulation.
  • Selection of the desired GMP controls that the Manufacturing Authorization Holder selects for implementation to ensure that the excipient quality is maintained.
  • Gap analysis of the excipient supplier cGMP controls with the GMP controls selected by the Manufacturing Authorization Holder in step 2 and assessment of the excipient supplier Risk Profile against the pre-selected GMP controls.

The final step in the process is to determine an ongoing plan of activity for the maintenance of the excipient quality from the selected supplier as per the GMP controls selected by the manufacturer as part of the Excipient Risk Assessment step 2.

Often the excipient supplier is managed solely through the supplier management program which maintains a link with the excipient risk assessment, but the two processes are inherently different and require separate consideration as per the EU guideline.

PharmaLex are uniquely placed to support your organization with risk management of excipients. As a company we have designed and developed software program SMARTRISK that includes a module dedicated to the correct completion of a Risk Assessment for Excipients. SMARTRISK is a user-friendly system that does not require additional IT knowledge. The program takes the user step-by-step through the various elements of the assessment, which are fully aligned with the EU Guideline 2015/C 95/02. Each sub-part of the Risk Assessment has visual graphics to make it very convenient to navigate and track progress. The system comes with different report format options that are signed and version controlled.
The system is hosted within the Microsoft Azure cloud platform and compliant with EudraLex Volume 4 – Annex 11 and 21 CFR part 11, with full audit trail functionality.

We have several subject matter experts available with in-depth experience of excipient risk assessment and the use of the SMARTRISK tool.

If you would like our Team to examine your Excipient Risk Strategy and demonstrate how SMARTRISK works for you, please connect with us to discuss


This blog is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise. However, PharmaLex US Corporation and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice. 

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