Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - Scientific guideline

This guideline applies to human and veterinary medicines.

This document concerns the potential for cross-contamination of medicinal products produced in shared facilities. It aims to recommend an approach for deriving a scientifically based safe threshold value for individual active substances to be applied for risk identification.Read together with Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...

Keywords: Shared facilities, risk identification, exposure limits, toxicological data, residual active substances, permitted daily exposure (PDE)

Current effective version

Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Adopted Reference Number: EMA/CHMP/CVMP/SWP/169430/2012 Summary:

When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a benefit to the intended patient or target animal; however as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk.

Document history - First version (current)

Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Adopted Reference Number: EMA/CHMP/CVMP/SWP/169430/2012 Summary:

When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a benefit to the intended patient or target animal; however as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk.

Overview of comments received on 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/ CVMP/ SWP/169430/2012...

Reference Number: EMA/CHMP/SWP/364535/2015

Draft guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Draft: consultation closed Consultation dates: 08/01/2013 to 30/06/2013 Reference Number: EMA/CHMP/CVMP/SWP/169430/2012 Summary:

The scope of this guideline is to ensure the safety of human patients and target animals exposed to residual active substances via medicinal products as well as consumers potentially exposed to residual active substances in products derived from treated food-producing animals. This document should be read in conjunction with corresponding GMP guidance in Chapters 3 and 5 of the GMP Guide published for consultation by the European Commission and can be found at:

http://ec.europa.eu/health/files/gmp/gmp_chapter3_en.doc

http://ec.europa.eu/health/files/gmp/gmp_chapter5_en.doc

Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities

Draft: consultation closed Consultation dates: 20/10/2011 to 31/01/2012 Reference Number: EMA/CHMP/SWP/598303/2011 Summary:

The Safety Working Party recommends drafting new guidance on toxicological assessment to be used in the risk identification stage of the Quality Risk Management process in determining whether a medicinal product should be manufactured in dedicated facilities.