Elemental Impurities

Data Sharing Initiative

Principal Global Alliance Manager

Crina.Heghes@lhasalimited.org

Dr. rer.nat Crina Heghes

Overview

Key Aspects• ICH Q3D

Elemental Impurities Data Sharing Initiative• Consortium aims and objectives

shared knowledge shared progress

ICH Q3D Key Aspects

• Changing regulatory guidance has led to the need to build

knowledge of EI levels in excipients

http://www.ich.org/products/guidelines/quality/article/quality-

guidelines.html

ICH Q3D Key Aspects

• Q3D :-

• Section 5 - Information for this risk assessment includes but is not

limited to: data generated by the applicant, information supplied by

drug substance and/or excipient manufacturers and/or data

available in published literature.

• Section 5.5 - The data that support this risk assessment can come

from a number of sources that include, but are not limited to:

• Prior knowledge;

• Published literature;

• Data generated from similar processes;

• Supplier information or data;

• Testing of the components of the drug product;

• Testing of the drug product.

Elemental impurities data sharing initiative

A proactive action from the pharma industry

Facilitate more scientifically driven elemental impurities risk

assessments under ICH Q3D, and reduce unnecessary

testing as part of the elemental impurities risk assessment

efforts.

• The data shared is analytical data generated to establish the

levels of trace metals within batches of excipients with

equivalent provenance to published literature

• Aims to save time and provide further evidence when partners

are setting the limits for the elemental impurities in the API

• Lhasa acts as the ‘honest broker’ and hosts the data within a

custom version of Vitic and facilitates the data sharing group

Elemental impurities data sharing initiative

Elemental impurities database

• The database contains the results of 33219 elemental determinations,

2304 analytical studies for 264 excipients.

• Next release: July 2019

Currently the largest known collection of this type of data

Vitic Nexus (version to date 12/06/2018) (Lhasa Limited), http://www.lhasalimited.org/products/vitic.htm

Database updates

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2016 2017 2018 2019

• Data is accessible to industry and regulators and can be used to

make it very clear why specific excipients are regarded as low

(negligible) or higher risk in a particular formulation at a given daily

intake.

• It should be easy to understand from the data and the risk

assessment why controls are required or not.

What is the vision of the database?

Who are the consortium and what they do?

What do the consortium do?

‘Testing’ impurities in strawberry mojitos????

…and when they do work….

What do the consortium do?

• Discuss and agree upon the scientific direction of the project

• Contribute and share expertise and knowledge

• Monitor the data provided by the member organisations and

ensure it meets predefined quality standards

• Identify data gaps and recommend priorities for work on the

project

• Lhasa Limited expertly curates the data from participating

organisations.

• Member organizations participating in the data sharing

initiative will join with the intent of regularly (e.g. annually)

providing EI data on non-proprietary excipients.

• Member organizations will contribute excipient elemental

impurities data to Lhasa utilizing a defined template.

https://www.lhasalimited.org/data-sharing-submission.htm

What do the consortium do?

Conclusions

• The feasibility of sharing excipient elemental impurity data has

been successfully demonstrated.

• Pooling and publishing data;

• Can help improve the ease with which risk assessments

can be completed

• Will give a better picture of which materials represent a

more significant risk than others

➢ Indicate where the risk is real & where it is negligible

• Reduce the amount of testing that is needed to be done

moving forward to support implementation

Acknowledgements

The Elemental Impurities Database Consortium steering group in 2019 is

chaired by Laurence Harris (Pfizer), and consists of the following

representatives:

Helmut Rockstroh (Hoffmann-La Roche), Christopher Day (AstraZeneca),

Andrew Teasdale (AstraZeneca), Fiona King (GlaxoSmithKline), Laura Rutter

(GlaxoSmithKline), Wilfried Keurentjes (MSD), Frans Maris (MSD), Peter

Jacobs (MSD), Nancy Lewen (Bristol Myers-Squibb), Mark Schweitzer

(Novartis), Radu Horga (Apotex), Lance Smallshaw (UCB), Juan Gil

(B.Braun), Elaine Shannon (Takeda), Philip Lienbacher (Takeda), Agnieszka

Ceszlak (ZF Polpharma), Valerie Chiva (Sanofi), and Enid Gatimu (Abbvie).

Grace Kocks (Lhasa Limited), Carol Marchant (Lhasa Limited), Crina Heghes

(Lhasa Limited).

Thanks to Lhasa’s Account Management team for providing all training and

technical support.

Obrigada!