Regulatory Affairs and Quality Systems

Overview

Summary of Lecture Content:
This module will examine the process which runs parallel to the production of the biopharmaceutical product - the need for regulatory alignment with a body to ensure that a product which is being marketed is of the highest quality and safe for use. Students will be taught in detail the different regulations which must be met for a biopharmaceutical product to be marketed and how these regulations may differ when moving from continent to continent. The module examines why such regulations are needed with reference to case studies.
Throughout the prior five modules, students will have looked at the different techniques and strategies employed to produce a biopharmaceutical on a technical, scientific level. This module however will provide context as to why some of the processes are carried out in a certain way and why this is the case. In terms of aligning theory with real world scenarios and understanding how process and regulation must go together, there will be discussion of the regulations set by the European Medicines Agency (EMA) and the U.S. Food and Drugs Administration (FDA), two of the biggest regulatory bodies with regards to biopharmaceutical products in the world.
Some of the hands-on experience that the students will gain will be in terms of preparing documents which would be needed for a biopharmaceutical drug to enter the market and ensuring that these documents are filled in correctly to align with each regulatory body. With regards to the quality assurance section of the module, students will examine the key processes behind the assurance side of biopharmaceutical production. By identifying the difference between quality assurance and quality control, students will be able to discuss what a quality assurance organisation is and defining the specific functions of each. There will be examination of instances when quality assurance failed and why this is a major problem when a drug has gone to market. Following the failure of a quality assurance, students will learn about the types of investigation which must be conducted to determine the severity of the failure and what must be done to rectify the issue.
The assessment for this module will consist of examination and coursework to be completed by students and submitted. Each component is worth 50% of the module score. This module will be delivered in its entirety by staff from our industrial partner Eli Lilly.

Section 1: Regulatory frameworks
This series of lectures will introduce the topic of the frameworks in place throughout the world which govern the production and marketing of biopharmaceutical products. This will include a more in-depth discussion around the role of the FDA and EMA on both sides of the Atlantic and the need for transparency in their protocols with regards to the production of biopharma products.

Section 2: Quality Assurance
This series will look at what it takes to have an organised structure when it comes to quality assurance within a biopharma production plant. Students will be appraised of the key differences between the acronyms associated with QA in the biopharma industry and be able to define each. The section will also explain how a process is designed according to standards set by international bodies (ISO) and how to ensure that good practices to maintain these standards are met at all times within the process.


Section 3: Quality Control
This lecture series will look at the key aspects behind the quality control carried out within a biopharma industry. On a more practical level, students will be taught about the types of testing which are carried out on a daily basis in a biopharma plant to ensure products which are ready for market all meet specific criteria. Following this, there will be a detailed overview of the need for investigations to be carried out when a test is failed, which will require students to critically evaluate and think about ways in which a product may have failed a test and how to design experiments which would allow a more robust set of results.

Summary of Workshops:
These workshops will facilitate discussion between academics and students. During the workshops, students will go through questions with the academic and this will provide an opportunity for students to see how the examination questions will be formatted and the best way to approach these questions.
• Workshop 1: Regulatory Frameworks
• Workshop 2: Quality Assurance
• Workshop 3: Quality Control

Summary of Module Delivery:
The three series above will be delivered in a face-to-face manner. Workshops have compulsory attendance with registers being taken.

Learning Objectives

At the end of the module students will be able to:
• Understand the need for regulatory frameworks throughout the world when applied to biopharma products
• Create documents comparable to those which are submitted in a real world scenario to a regulatory body
• Recognise how recent political decisions (Brexit) will necessitate the need for a new regulatory body within the UK and how this may apply to Northern Ireland
• Expand and define acronyms which are used extensively within the industry
• Understand that regulatory bodies such as ISO are key to ensuring that good practice is maintained at all times in an industrial process
• Critically examine a scenario where good and bad practices are being followed and discuss what needs to be improved/ maintained
• Define the difference between QC and QA and how it leads to an effective, safely run process and delivers the highest quality of product for marketing
• Examine tests of products and given appropriate information design experiments which could be used to test products and investigations following test failure

Skills

Skills associated with this module:
• Core skills in STEM
• Critical evaluation
• Analytical skills
• Communication and report writing skills
• Logical understanding
• Problem solving ability

Assessment

Course Requirements:
Coursework submission 50 %
Total Coursework elements must be passed at 50%

Assessment Profile
Element type Element weight (%)
1. Workshops 100
Mandatory workshop attendance.