VALD09006 2019 Commissioning, Qualification & Validation
This module is designed to provide an overview of the principles behind the commissioning and qualification of a biopharmaceutical production facility. The processes involved in the commissioning and qualification of the utilities and equipment used in a biopharmaceutical production plant will be covered throughout the module. A practical element is incorporated into the module, whereby students will gain an insight into the installation, commissioning and testing of the equipment and utilities used in biopharmaceutical manufacturing. It will equip students’ with the knowledge and skills required to perform commissioning of a bioprocessing plant, and the equipment related to the biotechnology industry.
On completion of this module the learner will/should be able to;
Outline and evaluate the stages involved in pre-commissioning, commissioning and start-up of facilities
Debate the principles involved in commissioning planning.
Evaluate the steps involved in testing of equipment
Outline and Evaluate the safety aspects of commissioning and installation of equipment
Critically evaluate the key industry guidelines and regulations that are used for CQV and differentiate CQV activities
Actively Participate in the activities designed to start-up and check a system in a logical, organised, safe, and controlled manner in a simulated GMP environment.
Teaching and Learning Strategies
This Module will be delivered part time.
This will include online lectures augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment.
Module Assessment Strategies
This Module is 100% Continuous assessment
Repeat continuous assessment in accordance with marks and standards and the quality manual.
This module is designed to provide an overview of the principles behind the commissioning and qualification of a biopharmaceutical production facility. The processes involved in the commissioning and qualification of the utilities and equipment used in a biopharmaceutical production plant will be covered throughout the module. A practical element is incorporated into the module, whereby students will gain an insight into the installation, commissioning and testing of the equipment and utilities used in biopharmaceutical manufacturing. It will equip students’ with the knowledge and skills required to perform commissioning of a bioprocessing plant, and the equipment related to the biotechnology industry. Topics covered will include some of the following: risk assessments, system definitions, commissioning planning, lock out tag out, commissioning procedures, commission test scripts, IQ, OQ, PQ, final acceptance preparation, close-out, legislation.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Continuous assessment-1 (10%) will involve a short written assignment||Continuous Assessment||Assignment||10 %||Week 4||1,2|
|2||Continuous assessment-2 (10%) will be a live online quiz, long answer question (LAQ) format||Continuous Assessment||Assessment||10 %||Week 7||1,2,3,4|
|3||Written project report (30%)||Project||Project||30 %||End of Semester||4,5,6|
|4||Technical Presentation||Continuous Assessment||Individual Project||10 %||End of Semester||4,5|
|5||NIBRT Practical assessment||Practical||Closed Book Exam||10 %||Any||6|
|6||Practical Report||Practical||Assignment||30 %||Week 13||2,3,4,6|
Part Time Mode Workload
|Independent Learning||Online||Self Study||6||Weekly||6.00|
Required & Recommended Book List
1997-12-05 Pharmaceutical Biotechnology CRC Press
ISBN 9057022486 ISBN-13 9789057022487
The first target group for this book is the pharmacists who wish to update their knowledge of biotechnology. A second target group is the present generation of pharmacy students at our universities; and thirdly, the pharmaceutical scientist who has not been in contact with modern biotechnology and wishes to familiarize him or herself with the principles of this fast moving field. Therefore, we hope that this book will be used at universities, in life-long learning courses, and in the professional environment of the pharmacist and industrial pharmaceutical scientist all over the world. For educational purposes, each chapter is concluded with a number of self-assessment questions and a number of literature references for further reading. The multicolor printing of the artwork in this book should assist the reader in mastering the contents of this book.
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
ICH, International Conference on Harmonisation (ICH) guidelines Q7, Section 18., ICH, 2003
PDA Technical Report-42 (2005) and PDA Technical Report-42 (2013)
ISPE, ISPE Base line Guide No. 6., ISPE, 2004
Kelly, D., Validation of Biopharmaceutical Manufacturing Processes., American Chemical Society, 2003
EU cGMPs Eudralex Annex 2 online (http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm)
Current FDA guidance for process validation.
United States code of federal regulations, series 600, available online (www.fda.gov)