What role do HBELs play in meeting the requirements of GMP Chapter 5 section 20?

Once the health based assessment has been completed and HBEL confirmed, these data should be used via a Quality Risk Management process to assess if current organisational and technical control measures are adequate, or in the case of new equipment/facility to determine what control measures are required. It is expected that the higher the hazard of products/active substances, the higher the inherent risk and the more significant organisational and technical control measures will be required. Health based exposure limits provide an accepted safe level of cross contamination and they should be used to justify cleaning limits.

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