Course Summary

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

Who will benefit from this module?

Everyone who works in, or has occasion to enter into, a manufacturing environment in the pharma/biotech industry should have access to this module.

Learning Objectives

• Explain what GMP is and why it is important
• List some historical events resulting from failures in manufacturing
• Identify sources of GMP rules in regulations and guidance
• List costly consequences of the discovery, by regulators, of serious breaches of GMP

Module Outline

Key topics covered in this module include:

• What is GMP?
• Why is it important?
• Lessons from history
• Regulations and guidance
• Regulatory inspections
• Regulatory and legal sanctions

Assessment - Multiple-choice assessment.