VALD09006 2019 Commissioning, Qualification & Validation

General Details

Full Title
Commissioning, Qualification & Validation
Transcript Title
Commissioning, Qualification &
Code
VALD09006
Attendance
N/A %
Subject Area
VALD - Validation
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
10 - 10 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler, Colin Fowley
Programme Membership
SG_SBCQV_E09 201900 Level 9 Certificate in Science in CQV Commissioning, Qualification and Validation for Biologics Manufacturing
Description

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.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Outline and evaluate the stages involved in pre-commissioning, commissioning and start-up of facilities

2.

Debate the principles involved in commissioning planning.

3.

Evaluate the steps involved in testing of equipment

4.

Outline and Evaluate the safety aspects of commissioning and installation of equipment

5.

Critically evaluate the key industry guidelines and regulations that are used for CQV and differentiate CQV activities

6.

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 Assessments

Repeat continuous assessment in accordance with  marks and standards and the quality manual.

Indicative Syllabus

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

Coursework & Continuous Assessment
100 %

Coursework Assessment

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


Type Location Description Hours Frequency Avg Workload
Lecture Not Specified Lecture 2 Weekly 2.00
Independent Learning Online Self Study 6 Weekly 6.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
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.

Required Reading
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

Module Resources

Non ISBN Literary Resources

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

ASTM E2500

Other Resources

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)

Additional Information

None