Module: Biopharmaceutical Industry Regulation & Management

Module Specifications.

Current Academic Year 2024 - 2025

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Date posted: September 2024

Module Title	Biopharmaceutical Industry Regulation & Management
Module Code	BE583 (ITS) / BTE1034 (Banner)
Faculty	Science & Health	School	Biotechnology
Module Co-ordinator	Denis Collins
Module Teachers	Brian Freeland, David Collins, Denise Harold, Paul Cahill
NFQ level	9	Credit Rating	5
Pre-requisite	Not Available
Co-requisite	Not Available
Compatibles	Not Available
Incompatibles	Not Available

None

Description

1. Module Aims: This module will provide a high level overview of the regulatory environment and the roles and responsibilities in which biopharmaceutical engineering professionals must operate. The focus will be on the increasing regulatory needs throughout the development lifecycle. A review of current good manufacturing practices (c GMP) associated with the manufacture of biological medicinal products for human use shall be undertaken and this shall be applied to the students own organisation and a gap analysis completed. As the landscape is driving for regulatory harmonisation emphasis on commonality and unique regional requirements shall be investigated. The entire value system of Regulatory importance shall be covered namely, the Institute for Chemical Harmonisation Guidance on Quality Systems ICH Qx, which addresses all current best practice aspects of Biopharmaceutical quality management This shall focus on Utilities, manufacturing and Quality test and release of products as required by regulation. 2. The module will take both a current and prospective look at the ever evolving regulatory requirements, applying the principles of quality by design and continuous improvements during biopharmaceutical development facilitate using a range of risk management tools, thereby building innovation into a proposed manufacturing process. This approach is based on the FDA’s initiative of cGMPs for the 21st Century. Process validation considerations for biopharmaceutical manufacturing will also be addressed, in terms of the process and quality attributes considered to be critical. A sound Quality system shall be designed using best practice from across the guidelines to act as a template for comparison to existing quality systems within the students organisation. As a focal point the role of Bioanalytical methodologies shall be investigated and the challenges associated with the validation and regulatory approval of Bioanalytical methods shall be explored.

Learning Outcomes

1. Define a best practice quality system for a biopharmaceutical manufacturing operation, understand where their own organisation fits relative to established best practice and be able to make recommendations to improve their own quality system and mitigate risk during site inspections.
2. Demonstrate an understanding of the drivers for regulation within the industry and to use basic project management tools to assist in risk mitigation studies of their own organisations
3. Outline procedures for managing compliance based on the cGMPs for the 21st Century initiative

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	16	No Description
Independent Study	109	No Description
Total Workload: 125

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Introduction to Regulatory Affairs & Quality Systems

The evolution of cGMP in Pharmaceutical Production

ICH Guidelines and their implications for operations

Quality by Design – Theory and Practice

The drug development cycle and the increased need for Regulation

Best Practice Internal Quality Management

Corrective Actions Vs Preventative Actions

Product Quality attributes – the importance of Structure and Function in Biopharmaceuticals

The challenges for Bioanalytics for process control

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
Assignment	Written Assignment	100%

Reassessment Requirement Type
Resit arrangements are explained by the following categories: Resit category 1: A resit is available for both* components of the module. Resit category 2: No resit is available for a 100% continuous assessment module. Resit category 3: No resit is available for the continuous assessment component where there is a continuous assessment and examination element.
* ‘Both’ is used in the context of the module having a Continuous Assessment/Examination split; where the module is 100% continuous assessment, there will also be a resit of the assessment
This module is category 1

Indicative Reading List

2004: ISPE Baseline® Pharamceutical Engineering Guides for New and Renovated Facilities, Biopharmaceutical Manufacturing Facilities (Part I of III), Volume 6, 316528
2005: Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, (Hardcover) Blackwell publishing Ltd, 316529
2004: Bioanalytical Chemistry, Imperial College Press, London,

Other Resources

65276, Guidelines, 0, ICH Guidelines Q6a, Q7, Q8, Q9, Q10, Q11, 65277, Guidelines, 0, EMEA Guidelines on comparibility,