Module Details

Module Code: PHAR S8019
Full Title: (Bio)Pharmaceutical Manufacturing and Supply Chain Management
Valid From:: Semester 1 - 2020/21 ( September 2020 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 7.5
Module Owner:: Richard Crowley
Departments: Life and Health Sciences
Module Description: Provide the student with the necessary knowledge and understanding of the manufacturing processes, equipment, tools, control systems and understanding of supply chain management requirements needed to function effectively in a highly regulated and controlled pharmaceutical manufacturing environment.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Categorise the manufacturing activities, inputs, outputs etc. using a Generic Process Approach model.
MLO2 Examine the key principles and methodologies used in a implementing a Lean/Six Sigma approach to manufacturing.
MLO3 Formulate the basic concepts associated with the design, layout, operation and control of clean rooms, how they are applied and used to maintain regulatory conformance.
MLO4 Interpret and explain the principles of tablet /capsule production systems and the associated control/measurement systems i.e. Manual, CLAS and CMMS.
MLO5 Explain how the principles of Cleaning, Decontamination and Sanitation (CDS), Cleaning In Place (CIP), Fogging are applied and how to provide and distribute Purified Water, Water for Injection and Clean Steam.
MLO6 Evaluate the importance of good Supply Chain Management regarding risk mitigation and continuous production.
Pre-requisite learning
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module Indicative Content
Manufacturing Process Approach -
Definitions, transformation process diagrams i.e.inputs, outputs, activities, deliverables etc. Flow Charts and Process Flow Diagrams
Site Selection and Premises Design
Criterion, decision and ranking matrix. Material, process and people flow. Weighing & Dispensing area design and environmental control
Premise and Regulatory GMP
Impact on and design of Ancillary, Storage, Production and Quality Assurance areas
Manufacturing GMP and regulatory requirements
How regulatory requirements impact personnel , premise and equipment,
Clean Rooms
Definitions and standards. Turbulent and Laminar flows. Layouts and design, including air locks, air showers and stepover benchs. Factors affecting effectiveness i.e. rest and occupancy. Air supply, distribution and filtration. Zone control and clean room clothing.
Water purification and distribution
Classification types and uses of water. Multistep purification process, Distillation and Reverse Osmosis, Distribution systems for WFI and PW.
Principles of steam generation – steam equipment, boilers.
Utility and Cleam steam. Generation and distribution of Clean Steam
CDS – Cleaning, Decontamination and sanitation
Cleaning, Decontamination and Sanitation (CDS). Clean In Place (CIP) and Fogging
Tablet Production Systems
Tablet forms and formulations, Physical propertie i.e. shape, size and strength. Granual an Dry compression mixes. Wet and Dry cranulation. Eccentric and Rotary presses. powder and granual delivery systems. Weight control systems i.e. Manual, CLAS and CMMS. Correlation betwen compaction force and weight.
Tablet Coating systems
Acid resistant v non resistant coatings. Types of coating processes
Capsule Filling Systems
Generic Filling steps. Filling methodologies, Plate, Auger, Tamping, Compression and Drug-pack
Supply Chain Management
Basic economics (incl. market conditions), Basic contract law, Corporate social responsibilities, code of ethics and anti-corruption, Strategy and planning, Distribution Channels, INCO Terms, Incoming inspection and warehouse controls, Stock Control, Risk management, Procurement and Vendors
Module Assessment
Assessment Breakdown%
Course Work20.00%
Practical20.00%
Final Examination60.00%
Module Special Regulation
 

Assessments

Part-time

Course Work
Assessment Type Class Test % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 1,2
Duration in minutes 0
Assessment Description
The test will evaluate knowledge, understanding and application of the subject matter covered in lectures and tutorials
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 20
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 4,5
Duration in minutes 0
Assessment Description
Laboratory practical workshop on practical
situations applicable to the manufacture of
biopharmaceutical products e.g. • How to
generate a signal: The science behind a pH
and/or dO2 probe. • Batch ultrafiltration of milk
powder solutions. • Dynamics of heat transfer
in a stirred tank reactor. • Dynamics of oxygen
transfer in a stirred tank reactor. • Evaporation
of sugar solutions. • Filtration in a bench top
filter cell. • Sedimentation of calcium
carbonate suspensions.
Final Examination
Assessment Type Formal Exam % of Total Mark 60
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4,5
Duration in minutes 0
Assessment Description
End-of-Semester Final Examination

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload

This module has no Full-time workload.
Workload: Part-time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 2.00 2
Independent Study Non Contact No Description Every Week 5.00 5
Directed Reading Non Contact No Description Every Week 3.00 3
Independent Study Non Contact Preparation for practical's and reporting results Once per semester 0.67 10
Practical Contact 2 Hrs x 4 Labs Once per semester 0.53 8
Total Weekly Learner Workload 11.20
Total Weekly Contact Hours 2.53
 
Module Resources
Recommended Book Resources
  • Augsburger L. Larry, Hoag W, Stephen. (2008), Pharmaceutical Dosage Forms- Tablets: Manufacturing and Process Control, 3. Informa healthcare, [ISBN: 978-0849390166].
  • Haider, Imtiaz Syed. (2006), Validation Standard Operating Procedures: Achieving Compliance in Pharmaceutical, Medical Devices and Biotech Industries, 2nd. Informa Healthcare, [ISBN: 978-0849395291].
  • Buckbee George, Alford Joseph. Automation Applications in Bio Pharmaceuticals, 2008. ISA, [ISBN: 978-1934394250].
  • LeBlanc L. Destin. (2000), Validated Cleaning Technologies for Pharmaceutical Manufacturing, Informa Healthcare, [ISBN: 978-1574911169].
  • Paikh, D.M.. (1997), Handbook of pharmaceutical granulation technology, Marcel Dekker Inc, [ISBN: 978-0824798826].
  • Allport-Settle J. Mindy. (2009), Current GMP Practices, Create Space Indep Publishing Platform., [ISBN: 978-144955236].
  • Whyte William. (2010), Cleanroom Technology: Fundsmentals nof Design, Testing and Operation, 2nd. Wiley, [ISBN: 978-0470748060].
  • Collentro V. William. (2010), Pharmaceutical Water: System: Design, Operation, and Validation, 2nd. CRC Press, [ISBN: 1420077821].
  • Lachman Leon. (2010), The theory an practice of industrial pharmacy, CBS Publishing and Distributors P Ltd, [ISBN: 978-8123916798].
  • Walsh, G. (2003), Biopharmaceuticals: Biochemistry and Biotechnology, Wiley.
  • Lachman Leon, Lieberman A. Herbert, Kanig L. Joseph. (1986), The Theory and Practice of Industrial Pharmacy, 3rd. Lea & Febiger, [ISBN: 978-0812109771].
This module does not have any article/paper resources
Other Resources