Principles of GMP (GMP01b)

Course Summary

In this short course we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.

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

• Describe ways of preventing contamination
• Outline precautions to prevent mix-ups
• Describe requirements for documentation
• List steps taken to validate and maintain processes and equipment
• Identify requirements for an independent Quality unit and self-inspection
• Outline training requirements
• Discuss the roles of quality assurance, GMP, and quality control in the company’s quality management system

Module Outline

Key topics covered in this module include:

• Prevention of contamination
• Prevention of mix-ups
• Documentation
• Validation and maintenance of processes and equipment
• Quality unit and self-inspection
• Training
• Quality management

Assessment - Multiple-choice assessment.