GMP

Adoption and Entry into Force of New PIC/S Guidance Documents (PI 052-1 and PI 053-1)

Geneva, 1 June 2020:  The following new PIC/S guidance documents have been successfully adopted: 

• PI 052-1 Aide-memoire – Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management
• PI 053-1 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’

The documents, which have been successfully developed by the PIC/S Expert Circle on Controlling Cross-Contamination in Shared Facilities, led by UK / MHRA, entered into force on 1 June 2020.

To download these documents (PI 052-1 and PI 053-1), please consult the page “Publications” or click on the links below:PI 052-1 Health Based Exposure Limit Aide-Memoire.pdfPI 053-1 HBEL QA.pdf