Training and Coaching of Regulatory Inspectors for WHO Good Manufacturing Practices on Sterile Pharmaceuticals

National regulatory authorities and ministries of health increasingly require inspectors who can assess sterile pharmaceutical products, vaccines, biotechnology products and other biologicals using a risk-based and evidence-led approach. Sterile manufacturing is a high-risk area because weaknesses in contamination control, aseptic processing, environmental monitoring, sterilization, utilities, data integrity, investigations or CAPA may have direct implications for patient safety and product quality. The underlying concept note recommends a staged, competency-based pathway consisting of self-paced online learning, instructor-led interactive core online course with substantial practical work, and three to six months of regular online mentored follow-up during which 5-working-day in-country training and coached mock inspection led by instructors in two targeted countries including Mongolia and Lao PDR. The course should be grounded primarily in WHO GMP main principles, WHO GMP for sterile pharmaceutical products, WHO GMP for biological products, WHO guidance on quality risk management, validation, water for pharmaceutical use, data integrity, inspection reporting, desk assessment, reliance and inspectorate quality management.