PIC/S publishes Guidance Documents on Remote Assessments
Recommendation

14-16 April 2026
Hamburg, Germany
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.
Related GMP News
03.12.2025What are GMP Audits and what Qualifications do GMP Auditors need to have?
19.11.2025Root Cause Analysis and CAPA - Why FDA Keeps Calling Them Out
22.10.2025EMA Questions & Answers on Mutual Recognition Agreement (MRA) with US updated
22.10.2025FDA continues to take Root Cause Analysis and CAPA very seriously

