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:
- Fully Interactive Remote Assessment
- Partially Interactive Remote Assessment
- Desktop Assessment
- 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:
- Preparation for a remote assessment
- Conduct of the remote assessment
- 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