Good Manufacturing Practice (GMP)

This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.

Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing and quality control of active pharmaceutical ingredients, foods, pharmaceutical products and medical devices. GMP regulations and guidance are designed to ensure that products are consistently produced and controlled to quality standards. Most countries have promulgated regulations and guidelines defining GMPs and require that pharmaceutical manufacturers comply with their own GMP guidelines.

This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety. It covers a wide range of issues, including why regulations were created and are enforced worldwide, how pharmaceutical companies ensure compliance with the regulations, reasons for making quality products, US and EU regulations, the consequences for failing to comply with any regulations and associated regulatory actions.

At a Glance

Target Audience: This course is designed for regulatory professionals interested in learning the basic GMP regulations and principles for the US and EU.

Learning Level: Basic

Total Length of Course: 4 Hours

RAC Points: 4

Medical Device Certificate Elective

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Describe CGMPs and why they exist

Define quality and state the reasons it is important

Identify the parts of a quality system

Discuss the role of the quality unit

Define the guiding values of the CGMPs