PIC/S: Guidance 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 will enter into force on 1 January 2025.

The PIC/S states that the remote assessment and hybrid inspection will have a place in an inspector‘s toolkit beyond the pandemic.

They soon will be available in our GMP knowledge portal, the GMP Compliance Adviser.

Guidance on remote assessments
The guidance distinguishes between fully interactive remote assessments, partially interactive remote assessments, desktop assessments, and hybrid inspections.
It covers the logistics and the technical requirements for remote inspections.

A feasibility check for a remote inspection using a risk assessment is mandatory. Factors to be considered include:

• Previous inspection history
• Activities carried out at site
• Length of time since last on-site inspection
• Information relating to the site from any regulatory authority / source
• Changes since last inspection
• Internet connectivity of site and of inspectors

Documentation requirements are also given. For example, the GMP certificate should clearly state whether the assessment/inspection was performed remotely, on-site or hybrid.

Aide Memoire on remote inspections
The Aide Memoire provides best practices and summaries for preparing and conducting remote assessments and post-inspection activities. It also provides prompts and questions to guide users through these processes.
Issues raised include, for example:

• Pre-inspection teleconference with the site
• Secure platform for sharing documents
• Connectivity test
• Need for an independent translator
• Daily tentative schedule to ensure the availability of subject matter exterts (SMEs)
• Site tours?
• What type of document will be issued after the remote assessment

Source:

PIC/S: News