PIC/S Sets Global Standards For Remote GMP Inspections

Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.

Engineer is using virtual reality glasses to inspect the factory's mechanical control system.
Remote GMP assessments were developed during the COVID-19 pandemic (Shutterstock)
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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Manufacturing

More from Geography