WHO vs FDA vs EU GMP: Documentation Requirements
📑 WHO vs US FDA vs EU GMP: Documentation Requirements Purpose Provide a comprehensive comparison of documentation requirements under WHO, US FDA, and EU GMP, highlighting audit focus areas and strategies for harmonized, inspection-ready systems. Importance of Documentation Documentation ensures: Traceability of processes, materials, and decisions Data integrity and accountability Compliance evidence during inspections Consistency and reproducibility of operations “If it isn’t documented, it didn’t happen.” WHO GMP Documentation Focus on essential SOPs, Master Formula, and Batch Records Simple structure suitable for global supply Limited electronic record emphasis Manual records acceptable if legible and controlled US FDA GMP Documentation Highly detailed batch records for every step Mandatory deviation, investigation, CAPA documentation Strict data integrity and 21 CFR Part 11 enforcement Extensive au...