PIC/S publishes Guidance Documents on Remote Assessments

PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment.

The Guidance document is intended to provide guidance on the approach and use of remote assessments including a hybrid inspection as inspection tools to establish consistency amongst Inspectorates. It discusses the logistics for conducting remote assessments, including necessary technical aspects.

PIC/S defines three types of remote assessments which vary depending on the level of interaction:

• Fully Interactive Remote Assessment
• Partially Interactive Remote Assessment
• Desktop Assessment

and one combination type "Hybrid Inspection".

The Aide-Memoire document utilises best practices for performing an interactive remote assessment, including hybrid inspections to assist GMP inspectors in the life cycle process of remote assessments. The Aide-Memoire should also contribute to a harmonised approach for remote assessments between the different PIC/S Members and foster reliance. Like a checklist, it includes prompts and questions to guide users through these processes.