Workshop on generation and use of Health Based Exposure Limits (HBEL)

20/06/2017 to 21/06/2017
Location: European Medicines Agency, London, UK
The aim of this workshop is to develop understanding of the use and application of Health-Based Exposure Limits (HBELs) in the context of quality risk management of cross contamination during the manufacture of different products in the same manufacturing facilities. The workshop is by invitation only and experts in toxicology and manufacturing quality representing the manufacturing industry will meet with regulators representing GMP/GDP Inspectors Working Group and Safety Working Party (human and veterinary sectors). The workshop reviews current experience from the industry in the implementation of recent guidance and experience from GMP inspections. Time will be spent discussing the Questions and Answers on this topic recently published by EMA for public consultation. The need for further industry guidance and the feasibility of developing a training program that could be used for inspectors and industry will also be explored.A summary of the discussions will be published.


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