The Current State of Global GMP Inspections

Last year, the COVID-19 pandemic required global regulatory agencies to reframe how they approach GMP inspections. Redica Systems Senior GMP Quality Expert Jerry Chapman has covered how these agencies responded in his Conference Spotlight articles where he writes about insights gained from influential industry and agency speakers at the leading industry conferences.

Below is a round-up of the articles he considers the most critical to understanding the state of GMP inspections at this time. 

A State-of-the-Art Virtual Inspection Methodology Using Mixed Reality Technology Gets High Marks from European Medicines Agency Inspector

Health Canada GMP Inspectors Turning to Video, Teleconferencing; Three Case Studies Presented

PIC/S GMP Inspection Reliance Guidance Helps Global Agencies During Pandemic

Russian Inspectorate Weighs in on Remote Audits and International Harmonization

Hosting a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase

Preparing for a Virtual FDA Inspection: Advice from Former FDA Investigator and Investigations Director Ricki Chase

Top 10 Pharma Inspection Findings from FDA, MHRA, and the Russian Drug Regulator

[Related: For more on remote inspections and remote audits, download the recent Redica Systems virtual panel on the topic.]