Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidance on Remote Assessments

Date
January 20, 2025
Category

EU Regulations

Description

On the 1st of January 2025 PIC/S published new guidance on Remote Assessments, together with an accompanying aide-memoire.

The 12-page guidance 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 provides shared definitions and hopes that these and a consistent approach will:

  • Improve inter-agency communication,
  • Facilitate GMP Inspection reliance,
  • More efficient use of global inspection resources.

PIC/S see this guidance being applicable in the following areas:

  • Travel restrictions, e.g., pandemic situations, safety,
  • Re-Inspections if a manufacturer demonstrates good levels of compliance in previous inspections and when the activities of the inspected site are limited (e.g. agency policy)
  • Verification of certain aspects of Corrective and/or Preventative Actions
  • Rapid Assessment of GMP aspects in specific circumstances where there is an immediate need.
  • To gather information for an inspection

The guidance defines three types of remote inspection and one combination type:

  1. Fully Interactive Remote Assessment
  2. Partially Interactive Remote Assessment
  3. Desktop Assessment
  4. Hybrid

It then provides detailed guidance under the following headings:

  • Logistics for Remote Assessments (including Hybrid Inspections)
  • Feasibility Approach to Remote Assessment (including Hybrid Inspection)
  • Remote Assessments Documentation
  • Follow-up on Remote Assessment Effectiveness

The accompanying Aide-Memoire utilises best practises for performing an interactive remote assessment, including hybrid inspections, and provides detailed lists of things to consider under the following headings:

  1. Preparation for a remote assessment
  2. Conduct of the remote assessment
  3. Post assessment activities for a remote assessment.

The new Guidance and the Aide-Memoire can be found on the PIC/S website www.picscheme.org