Two new PICS Documents on Remote Assessments published

Summary 
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:

Summary

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.

Comments

Popular posts from this blog

FDA describes detailed CAPA Procedure in Warning Letter

FDA Warning Letter Missing Ongoing Stability Studies for APIs

Understand ICH Q7