REGU09022 2019 Regulation, Risk and Compliance
This module aims to provide students with an understanding of the main regulations and regulatory bodies associated with biopharmaceutical manufacturing and how they translate into this environment. It also provides students with the application of the validation concepts and how risk management is an integral part of this.
On completion of this module the learner will/should be able to;
Demonstrate an understanding of the global regulatory framework for biotechnology derived products
Discusss the nature and production of biotechnology products affects quality, safety and efficacy
Differentiate the applications of EU & US regulations for biopharmaceutical marketing authorisations
Categorise the principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them
Critically evaluate the main steps involved in the validation of upstream (cell culture processing) and downstream (protein purification) processes as well as cleaning, sterilisation and viral control technologies in the manufacture of biopharmaceuticals.
Engage in and demonstrate independent learning as well as communicate effectively as an Individual and or a member of a team
Teaching and Learning Strategies
This module will be taught using on‑line lectures. A range of Computer‑Aided Learning (CAL) packages are also used to support this module (e.g. Moodle,Adobe Connect, Panopto, Camtasia). Students are provided with electronic materials for self‑assessment and preparation for assessments/assignments. Self‑directed, student‑centred, independent learning is a core aspect through completion of module coursework.
Module Assessment Strategies
The assessment approach for this module will be 100% continuous employed including some of the following: Enquiry based Projects, Assignments/mini projects including Viva/Presentation Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions.
Students will have opportunities to re-submit work as agreed with their lecturer.
Section 1 Legislation
Overview of the EMA, FDA, and ICH. Introduction to Clinical Trials and Drug Development (CTA, IMPD, IND)
Section 2 Biologics
TSE risks Advanced Therapies Biosimilars QBD FDA & EU GMP regulations for pharma/biopharma manufacture
Section 3 Validation
Validation Validation Master Plan, validation life cycle, and risk management Upstream and Downstream, Cleaning and Viral Clearance
Section 4 Risk
Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture (ICH Q9).
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||MCQ 1||Continuous Assessment||Multiple Choice||10 %||Week 5||1,2|
|2||MCQ 2||Continuous Assessment||Multiple Choice||10 %||Week 9||3,4|
|3||End of Semester Assessment||Continuous Assessment||Assignment||20 %||Week 12||1,2,3,4,5|
|4||Project & Viva||Project||Closed Book Exam||40 %||Week 12||1,2,3,4,5,6|
|5||Gp Project||Project||Group Project||20 %||Week 11||2,3,4,5,6|
Part Time Mode Workload
|Independent Learning||Not Specified||Self Study||7||Weekly||7.00|
Required & Recommended Book List
2007-09-25 Validation of Pharmaceutical Processes, Third Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions
2013-04-25 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9781118685754 ISBN-13 111868575X
Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific product category chapters focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed
Pharmaceutical Drug Regulatory Affairs Journal