The Elemental Impurities project is a collaborative data-sharing project; one of several projects initiated by the pharmaceutical industry, in partnership with Lhasa Limited, which enables pre-competitive data sharing.
This collaboration is designed to share analytical data on the levels of trace elements within batches of excipients used in the formulation of pharmaceutical drug products. The aim of the collaboration is to increase the understanding of the level of risk posed by elemental impurities present in excipients.
The following points provide a greater insight into the Vitic Elemental Impurities data sharing project:
- This project is particularly useful for Pharmaceutical companies wishing to assess the potential elemental impurities in their final drug products, but is also relevant for suppliers of excipients.
- The ICH Q3D guideline for elemental impurities introduces permitted daily exposure (PDE) limits for 24 elements. It is widely known how to apply PDEs in industry; however, there remains an incomplete picture of the levels present in all formulations, and in particular the risk associated with excipients used in the formulated product.
- The project involves an extension of the Vitic database.
- Members of the Vitic Elemental Impurities Database contribute a specified amount of data generated to establish the levels of trace metals within batches of excipients.
- The amount and quality of data required from each member is decided by the Project Steering Group, and this amount is reviewed regularly on a fair, reasonable and non-discriminatory basis.
- A Project Steering Group has been set up comprising of representatives chosen by the organisations contributing to the Vitic Elemental Impurities database. This group is led by an elected chairperson and has many responsibilities, including:
- Discussing and agreeing upon the scientific direction of the project.
- Contributing expertise and knowledge.
- Monitoring the data provided by the member organisations and ensuring it meets predefined quality standards.
- Recommending priorities for work on the project.
- Lhasa Limited acts as an honest broker and expertly curates the data from participating organisations. This allows a level of anonymity, whereby the submitting companies are known to each other, but who submitted what is known to Lhasa Limited only.
The most recent Elemental Impurities Database, 2018.1, contains:
- 2,304 data records in the Elementals Table
- 4,910 data records in the Summary Table
- This data covers 264 excipients
The benefits that can be achieved by joining the data sharing consortium include:
- Utilise Proprietary Data: Joining this data sharing venture gives you the chance to make use of existing information on Elemental Impurity levels, present in a wide range of pharmaceutical excipients, that is not in the public domain.
- Advancing the Knowledge of Elemental Impurities: The sharing of data with others facilitates more scientifically driven elemental impurities risk assessments.
- Continually Expanding Database: Consistent member contributions mean that the database is constantly growing.
Lhasa Limited - an honest broker and trusted holder of data
Lhasa is a not-for-profit organisation and believes that shared knowledge can lead to shared progress. Recognised as the original "Honest Broker", Lhasa Limited has repeatedly been trusted with proprietary data and this can be seen with our involvement in other collaborative data sharing projects.
To find out more about data sharing opportunities at Lhasa Limited, please get in touch.
Marchant et al. (2018) 'An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment', Journal of Pharmaceutical Sciences, online.
Teasdale, A. (2016) 'ICH Q3D: Practical implementation and the role of excipient data in a risk based approach', AstraZeneca, as part of a Lhasa Limited webinar.
Kocks, G. (2018) 'Sharing Elemental Impurity Data for Excipients Aids ICH Q3D Risk Assessments', Lhasa Limited.