Course Code: TC-GMP-00 | Version: 1.0 | Duration: 3 hours | Level: Foundation — no prior GMP experience required
Course Overview
Good Manufacturing Practice is the foundation of everything that happens in a pharmaceutical, biotechnology, medical device or food manufacturing environment. It is the set of principles, systems, standards and practices that ensure every product manufactured is safe, effective, of the right quality and fit for its intended purpose. GMP is not a choice — it is a legal obligation in every regulated market in the world, and it is a moral obligation to every patient who depends on the medicines and devices we manufacture.
This course is designed for everyone who works in or with a GMP-regulated environment — whether you are a production operator, a laboratory analyst, a maintenance engineer, a warehouse operative, an IT specialist, a finance manager whose work touches GMP systems, or a new graduate beginning a career in the life sciences industry. You do not need prior GMP knowledge. You need only a willingness to understand why GMP matters — and how your personal role, however it may seem to relate to manufacturing, directly contributes to patient safety.
By the end of this course, you will understand what GMP is, why it exists, what it requires, who enforces it, and what happens when it fails. You will be equipped to begin or continue your GMP career with the foundational knowledge every person in a regulated organisation needs.
Learning Objectives
On completion, learners will be able to:
- Define Good Manufacturing Practice and explain why it exists
- Describe the historical events that led to modern GMP regulations
- Identify the major GMP regulatory authorities and their applicable regulations across key global markets
- Explain the seven pillars of GMP: People, Premises, Equipment, Processes, Materials, Documentation and Quality Systems
- Describe the key types of GMP documents and records and explain how they support compliance
- Understand the importance of data integrity and ALCOA+ principles in everyday GMP work
- Explain the role of GMP inspections and what regulatory authorities look for during site visits
- Identify the most common GMP failures and their consequences for patients and organisations
- Describe the career pathways available in GMP-regulated industries and the role each function plays
- Understand their personal responsibility for GMP compliance regardless of their role
Audience
All new hires; non-GMP staff; support functions; refresher for existing staff
