Professional & Industry
GMP — Good Manufacturing Practice
A practical introduction to GMP principles, quality management systems, documentation and data integrity for pharmaceutical and life-science environments.
Learning outcomes
- • Explain core GMP principles and their regulatory rationale
- • Describe QMS structure, QA vs QC responsibilities
- • Apply scientific documentation and data-integrity (ALCOA+) principles
- • Outline a CAPA workflow and deviation handling
- • Summarise fundamentals of regulatory compliance
Curriculum
Module 1 — GMP Foundations
- • History and rationale
- • Core GMP principles
- • Facility and personnel requirements
Module 2 — Quality Management Systems
- • QMS architecture
- • QA vs QC
- • Change control
Module 3 — Documentation & Data Integrity
- • Good documentation practice
- • ALCOA+
- • Audit trails
Module 4 — Deviations & CAPA
- • Deviation classification
- • Root cause analysis
- • CAPA lifecycle
Module 5 — Regulatory Compliance Fundamentals
- • Inspection readiness
- • Common findings
- • Continuous improvement
Who is this for
- • Pharmacy and life-science graduates
- • QA/QC staff in early roles
- • Laboratory professionals moving into industry