Assessment of potential human health risks arising from the manufacture of a new licensed product in a shared manufacturing facility

Background

The company intended to manufacture a new multi-ingredient pharmaceutical product at a shared manufacturing facility. Pharmaceutical good manufacturing practice (GMP) makes it incumbent on manufacturers of multiple pharmaceutical actives to ensure that cross-contamination of products does not present a health risk to patients. The European Medicines Agency (EMA) provides guidance on evaluation processes to provide such reassurance.

Client

A manufacturer of nutritional products.

Project goals

Bibra was asked to provide a human health risk assessment of the product in this respect, based upon the worst-case assessment of potential cross-contamination as supplied by the client.

Approach

The product was considered to fall outside of the intended scope of the EMA guidance as the ingredients are either essential to, or beneficial for, the general population; it was therefore considered unnecessary to calculate a permitted daily exposure (PDE) value for all ingredients. However a health-precautionary approach was adopted, with a risk assessment conducted and worst-case exposure estimates calculated for the highest percentage product ingredient and three further ingredients of particular interest. As all four substances are well studied, and expert group reports and other expert and/or comprehensive reviews are the most appropriate data sources for human health risk assessment, searches were undertaken using the bibra TRACE database (an unrivalled data source for identifying such review documents).

Project outcome

The worst-case exposure estimates for each of the four ingredients fell well below their respective health criteria values (HCVs) established by expert groups, indicating that any potential cross-contamination with the new product would not pose a risk to human health.

Bibra project team

 

Tanya Diver

James Hopkins

Pete Watts

 

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