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Global Pilot Reduces Drug Manufacturing Inspections With Hybrid Approach

 
• By Vibha Sharma

A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.

Scientist Medical Factory Staff Working in Science Lab. Medicine factory Technician Employee Check Care Products Quality in Sterilize Room Taking Note in Check list.
Collaborative hybrid GMP inspections can reduce duplicative checks by regulators (Shutterstock)
Key Takeaways
  • The International Coalition of Medicines Regulatory Authorities has issued a report on its collaborative inspections pilot, demonstrating effective simultaneous evaluations of drug manufacturing sites by multiple regulatory authorities.
  • The three joint hybrid inspections conducted under the pilot were completed within the agreed timetable and resulted in reduced individual inspections for the participating companies.
  • The pilot will continue throughout 2025 with a revised focus.

An international pilot that allowed companies to have their applications for increasing drug manufacturing capacity to be simultaneously evaluated by multiple regulatory authorities has yielded positive results for industry and...

The collaborative hybrid inspection pilot (CHIP), run by the International Coalition of Medicines Regulatory Authorities (ICMRA), enabled multiple regulatory authorities to approve applications to make manufacturing changes through joint inspections...

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