Good Manufacturing Practices (cGMP) - Intermediate

cGMP – Cases from History and the Regulations

In this course we will discuss some of the cases from history where the lack of GMP caused devastating effects for patients using medicines. Through the use of real life case studies, it should be very apparent how important it is to take GMP seriously. We will also cover how GMPs differ in other countries and what aspects of manufacturing does GMP not cover.

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CEU Credits: 0.1

Course Code: ELM-201

Duration: 30 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: V3.1

Curriculum for this course

Introduction

Overview

Learning objectives

Who should take this course

Program introduction

Module overview

Module 1: The Starting Line

Overview

What is GMP

What is cGMP

World Health Organization (WHO)

Why GMP?

Module 2: Cases From History

Overview

Cases from history

1930 - Lubeck BCG Vaccine

1938 - Sulpanilamide

1940 - Contaminated Caps (Lambert, E.C)

1955 - Polio vaccine (Cutter Laboratories)

1962 - Thalidomide

Why GMP is so important?

Module 3: GMP Regulations and the Guidelines

Overview

GMP regulations and guidelines

How do GMP's different in other countries

WHO

ICH

EMEA

MHRA

US FDA

GMP concepts

What aspects of manufacturing does GMP cover

Conclusion

Final Exam

Certification

Revision History

Minor Update: Course updated to fix an issue where learners could bypass the exam. The course now requires learner to complete the exam. Course navigation updated to new navigation standards

V3.1

Updated learning objectives to align with the course concepts and content. Updated the final exam with new questions to assess mastery of the updated learning objectives. Updated the final exam to create a question pool from which the course will randomly select at a 3:1 ratio for a total of 10 assessment questions on each final exam attempt.

V3.0

For the multiple-choice question “GMP is so important because: (Select all that apply)”, the system requires the answer “It allows pharmaceutical manufacturers to increase the price of their drugs” which is an incorrect statement in General but also per the information provided in the video. This answer was changed to incorrect.

V2.0