Full Title:Pharmaceutical Manufacturing
Language of Instruction:English
Module Code:MNUF S7001
 
Credits: 5
Valid From:Semester 1 - 2013/14 ( September 2013 )
Module Delivered in 3 programme(s)
Module Description:Provide the student with the necessary knowledge and understanding of the manufacturing processes, equipment, tools and control systems needed to function effectively in a highly regulated and controlled pharmaceutical manufacturing environment.
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Analyse the the Process Approach to Product Realisation (i.e. Manufacturing activities, inputs, outputs etc.) including Process Flow Diagrams (PFD’s)
  2. Explain and analyse how cGMP and regulatory requirements impact the design, layout, construction and finish of manufacturing Facilities and Premises.
  3. Describe how the basic concepts associated with the design, layout, operation and control of clean rooms (including Laminar Flow) are applied and examine the relevant standards that are used to maintain regulatory conformance.
  4. 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.
  5. Examine and discuss the principles of tablet production systems, the formulation and pressing of powders/granuals, capsule filing and coating technologies and the compare and contrast the associated control systems i.e. Manual, CLAS and CMMS.
 

Module Content & Assessment

Indicative Content
Manufacturing Process Approach -
Definitions, transformation process diagrams i.e.inputs, outputs, activities, deliverables etc. Flow Charts and Process Flow Diagrams
Patents
Novelty, obviousness, disclosure and utility. Product, process and use
Regulatory Authorities
FDA, EMEA, PAB, organisational structure, purpose/objectives, processes and areas of responsibility. The need for and application of cGMP.
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
Assessment Breakdown%
Course Work40.00%
End of Module Formal Examination60.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Project The project will be based on researching, analysing and applying best prasctices in manufacturing technologies or cGMP in the context of a highly regulated environment. 1,2,3,4,5 20.00 0 0 n/a 0
Class Test The test will evaluate knowledge, understanding and application of the subject matter covered in lectures and tutorials 1,2,3 20.00 0 0 n/a 0
No Project
No Practical
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam End-of-Semester Final Examination 1,3,4,5,2 60.00 0 0 End-of-Semester 0

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

 

Module Workload & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture No Description 2.00 Every Week 2.00
Tutorial No Description 1.00 Every Week 1.00
Directed Reading No Description 30.00 Once per semester 2.00
Independent Study No Description 30.00 Once per semester 2.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Tutorial No Description 0.00 Every Week 0.00
Total Weekly Learner Workload 0.00
Total Weekly Contact Hours 0.00
Resources
Recommended Book Resources
  • Augsburger L. Larry, Hoag W, Stephen 2008, Pharmaceutical Dosage Forms- Tablets: Manufacturing and Process Control, 3 Ed., Informa healthcare [ISBN: 978-0849390166]
  • Haider, Imtiaz Syed 2006, Validation Standard Operating Procedures: Achieving Compliance in Pharmaceutical, Medical Devices and Biotech Industries, 2nd Ed., Informa Healthcare [ISBN: 978-0849395291]
  • Buckbee George, Alford Joseph, Automation Applications in Bio Pharmaceuticals, 2008 Ed., 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 Ed., Wiley [ISBN: 978-0470748060]
  • Collentro V. William 2010, Pharmaceutical Water: System: Design, Operation, and Validation, 2nd Ed., 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 Ed., Lea & Febiger [ISBN: 978-0812109771]
This module does not have any article/paper resources
Other Resources

Module Delivered in

Programme Code Programme Semester Delivery
DK_SPHAR_7 Bachelor of Science in Pharmaceutical Science 5 Mandatory
DK_SGMPP_7 Certificate in GMP in Pharmaceutical Manufacturing 2 Mandatory
DK_SBIOP_8a Diploma in Biopharmaceutical Processing 2 Mandatory