Good Manufacturing Practice (GMP) is the global standard ensuring pharmaceutical products are consistently produced and controlled to quality standards. This ISO Xpert Academy certification course delivers comprehensive training across 8 modules and 40+ lectures, transforming complex regulatory requirements into clear, practical, workplace-ready knowledge.
You will master GMP fundamentals from the Sulfanilamide disaster and Thalidomide tragedy to modern FDA, EMA, PIC/S, WHO, and ICH frameworks. The course provides deep coverage of Quality Management Systems, distinguishing Quality Assurance from Quality Control, and integrating ICH Q10 pharmaceutical quality system elements with robust CAPA and change management.
ISO Xpert Academy guides you through ICH Q9 risk management tools including FMEA, Fault Tree Analysis, and HACCP, alongside formal change control and deviation management. You will learn personnel qualifications, training documentation, and hygiene programs; facility design, cleanroom classification, HVAC, and environmental monitoring; plus equipment qualification (IQ/OQ/PQ), preventive maintenance, and calibration.
Documentation modules cover GMP document hierarchies, Master Production Records, Good Documentation Practices (GDP), ALCOA+ data integrity, and electronic records/signatures under 21 CFR Part 11 and EU Annex 11. Production modules address process validation lifecycle (Stage 1–3), material management, in-process controls, and packaging/labeling controls including serialization and line clearance.
Quality Control and Laboratory sections explore QC facility requirements, analytical method validation per ICH Q2(R1), stability studies under ICH conditions, and rigorous Out-of-Specification (OOS) investigation protocols.
The course concludes with two landmark case studies the 2008 Heparin contamination crisis and the New England Compounding Center meningitis outbreak demonstrating the devastating consequences of GMP failures and the critical importance of supply chain security, environmental control, and quality culture.
By completing this course, you will be prepared to contribute to GMP-compliant operations, support audits and inspections, manage documentation and validation activities, and uphold the quality standards that protect patient safety worldwide.
