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. The consortium aims to facilitate more scientifically driven risk assessments under ICH Q3D.
Set up in 2015, the Elemental Impurities collaboration is designed to share analytical data on the levels of trace elements found in excipients that are used in the formulation of pharmaceutical drug products. The first Elemental Impurities Excipient Database was released in 2016 and since then, its members have regularly donated analytical data. Lhasa Limited acts as the ‘honest broker’ and facilitates the data sharing and expertly curates the data donated.
The Vision: The shared data is accessible to both industry and regulators with the aim to increase the understanding of the risk level posed by these 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 consortium, and this amount is reviewed regularly on a fair, reasonable and non-discriminatory basis.
- 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, 2019.1, contains:
- 39,517 elemental determinations
- 2,633 data records in the Elementals Table
- 5,563 data records in the Summary Table
- This data covers 295 excipients
Figure 1 illustrates the growth of the database from 2016-2019.
The Elemental Impurities Excipients Database is currently the largest known collection of this type of data.
Figure 1: shows the record numbers in the elemental impurities excipient database from 2016-2018.
The benefits that can be achieved by joining this data sharing consortium include:
- Utilise Proprietary Data: Joining this data sharing initiative gives you the chance to make use of existing information on elemental impurity levels, present in a wide range of excipients, that is not available in the public domain.
- Aid ICH Q3D Risk Assessments: The data in the Elemental Impurities database has the same origins as published literature and can therefore be a useful source of information for facilitating scientifically driven ICH Q3D assessments.
- Regulatory Engagement: Two regulatory bodies have been introduced to the database and two pharmacopoeias are actively using the database to review monographs.
- Save Time: Data in the Elemental Impurities database can be used for supportive drug product testing, to confirm conclusions of low risk and ensure that appropriate controls have been established. Longer term, it is envisaged that the database will reduce the requirement for drug product testing to support implementation of ICH Q3D in certain circumstances (e.g. for oral drug products where sufficient data exist to support a conclusion of low risk).
- Continually Expanding Database: Consistent member contributions mean that the database is constantly growing and therefore a better indication of risk is given.
The consortium consists of pharmaceutical companies with an interest in the sharing of elemental impurity data for excipients. Consortium members contribute data they generate to establish the levels of trace metals within batches of excipients. Two excipient suppliers have also made contributions to the database.
The consortium takes quality of data seriously and as such, all shared data conforms to predefined quality standards.
To ensure the continued success of the project, the consortium comprises of an elected chairperson and technical, regulatory and promotional sub-groups. The consortium has regular meetings to:
- Discuss and agree upon the scientific direction of the project
- Contribute expertise and share knowledge
- Recommend priorities for the consortium and the database
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, September 2018, Volume 107, Issue 9, Pages 2335 - 2340. https://doi.org/10.1016/j.xphs.2018.04.009
- 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', presented by Lhasa Limited at the 2nd Impurities: Genotoxic & Beyond Summit.