Quality Management Systems and Regulatory Affairs


This module reviews the key regulatory requirements for (bio)pharmaceutical product development, production and marketing.  It addresses the role of quality management in determining key factors such efficacy, purity and safety.  It describes the ISO 9000 quality standard requirements of biopharmaceutical manufacturing and addresses the role of ISO 9000 certification in achieving these standards.  It describes the difference between quality standards and international regulatory requirements and how quality management is associated with regulatory compliance.  It addresses the regulatory requirements of various international regulatory authorities such as the FDA and EMA, National Authorities (i.e..HPRA) and describes the role of the more general ICH guidelines in meeting regulatory requirements.

Learning Outcomes

  1. Demonstrate a clear understanding of the role of quality assurance throughout the lifecycle of a biopharmaceutical product and identify key elements monitored by the quality control system in the manufacture of a biopharmaceutical drug. 

  2. Evaluate the regulatory demands of agencies such as the European Medicines Evaluation Agency (EMA) and Food & Drug Administration (FDA) in terms of the development, production, characterisation and evaluation of biopharmaceutical products

  3. Evaluate Critical Quality Attributes (CQA) for biopharmaceutical manufacturing and critically analyse CQAs that demonstrate compliance with regulatiions for different types of biopharmaceuticals.

  4. Analyse the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in regulating biopharmaceutical drugs and apply QbD principles to the step-by-step development of a purification process for a biopharmaceutical drug

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