Europe – PIC/S adopts cross-contamination, HBEL guides

Following their adoption last month, two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents entered into force this week, a questions and answers guidance on implementing risk-based prevention of cross-contamination and an aide-memoire on health-based exposure limit (HBEL) assessments.
 
Both documents were adopted on 22 May 2020 following development and review by the PIC/S Expert Circle and entered into force on 1 June 2020.
 
The first of the two documents, 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 Medicinal Products in Shared Facilities,’ is based on and transposed from the European Medicines Agency’s (EMA) guideline of the same name…