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

• Date:
  Tuesday, 20 June 2017, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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

Reference Number: EMA/410936/2017

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

Reference Number: EMA/274950/2017

Presentation - Health-based exposure limits and Q&As (G. McKilligan, MHRA)

Presentation - Setting health-based exposure limits for highly hazardous products to ensure patient safety – application of the Q&A (R. Frà¶tschl, BfArm)

Presentation - Inspection findings on health-based exposure limits and cross contamination (G. McKilligan, MHRA)

Presentation - Key messages from industry / associations (J. Berridge)

Presentation - Case study: Setting health based exposure limits throughout the product life cycle (B.D. Naumann, ISPE)

Presentation - Key points to recognize quality in health based exposure limits and associated monograph (E. Lovsin Barle, PDA)

Presentation - Key expectations on inspection with regard to risk management of required organisational and technical control measures based on an established health based exposure limits (H. Carstensen, State Social Ser...

Presentation - Workshop on generation and use of health based exposure limits (J-L. Golnez, FAMHP)

Presentation - Case study: Evaluation of health based exposure limits and potential impact on manufacturing equipment cleaning limits (G. Allison, EFPIA)

Presentation - Case study: Application of health based exposure limits in a cleaning validation (A. Engwicht-Lassmann, IFAH)

Presentation - Case study: Risk assessments for cross contamination (S. Wilkins, ISPE)

Presentation - Inspection of cross contamination controls in shared facilities (G. McKilligan, MHRA)