Key Takeaways
- The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has issued harmonized recommendations to help good manufacturing practice inspectors plan, conduct and follow-up on remote and hybrid assessments.
- The recommendations are detailed in a guidance document and a related aide-mémoire that came into effect on 1 January 2025.
- The guideline offers common definitions and terminologies, and recommends, among other things, taking a risk-based approach to determine the suitability of a site for remote assessment.
- The aide-mémoire outlines best practices for inspectors to plan and execute remote assessments.
The international Pharmaceutical Inspection Co-operation Scheme (PIC/S), which works towards harmonizing manufacturing inspection procedures worldwide, has issued recommendations to promote a consistent approach to
Among the topics it has addressed is determining whether high-risk facilities are
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