Peer review of two HBEL assessments

Background

A contract manufacturer of pharmaceuticals required bibra to peer review its Health-Based Exposure Limit (HBEL) assessments in line with European Medicines Agency (EMA) guidance (EMA, 2014).

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177735.pdf

Client

A pharmaceutical contract manufacturer.

Project goals

The client had documented two HBEL assessments and bibra was asked to peer review these for accuracy, completeness and compliance with EMA guidance.

Approach

The EMA guideline provides for risk identification in the manufacture of different medicinal products in shared facilities, recognising the potential for cross-contamination and subsequent exposure of non-target patients for whom there is no benefit. The HBEL is a safe threshold value and is derived using an approach based on that used for establishing a Permitted Daily Exposure (PDE).

Project outcome

A peer review summary was provided to the client, describing the searches undertaken to ensure that no significant toxicological information had been overlooked, an evaluation of whether the product was ‘highly hazardous’, the various minor reporting issues identified in the client’s HBEL assessment documents, a check of the HBEL calculations themselves (including the selection of modifying factors) and a final conclusion in each case that the HBEL was appropriate. The client subsequently informed us that an audit of this work by the MHRA inspectorate was successful.

Bibra project team

Anne Edwards
Pete Watts

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