ACE

PF1801: Technical Effectiveness ll (Pharma Manufacturing)

Credit Weighting: 10
No. of Students:
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semesters 1 or 2 or 3. (semester details for this module will be confirmed at the start of the programme).
Teaching Methods: 48hr(s) Lectures (class based lectures and workshops); Other (self-directed learning)
Module Co-ordinator: Dr Séamus O Tuama, Centre for Adult Continuing Education.
Lecturer(s): Staff, Centre for Adult Continuing Education.
Module Objective: This module aims to introduce students to key processes and operations within a pharmaceutical manufacturing environment.
Module Content: Quality and cGMP compliance systems
Pharmaceutical plant design and layout
Processes involved in drug substance manufacture
Processes involved in drug product manufacture.
Learning Outcome: On successful completion of this module, students should be able to:
  • Demonstrate understanding of the principles of quality and cGMP.
  • Explain the principles behind pharmaceutical facility design.
  • Discuss principles behind key pharmaceutical unit operations.
  • Describe the key processes and associated controls involved in drug substance manufacture.
  • Describe the key processes and associated controls involved in drug product manufacture.
Assessment: Total Marks 200: Continuous Assessment 200 marks (Creation of an SOP, 50 marks; 1 x 1,000 word essay, 50 marks; In-class MCQ, 50 marks; Group project and Team presentation, 50 marks).
Compulsory Elements: Continuous Assessment. Oral if required.
Penalties (for late submission of course/project work etc.): Where work is submitted up to and including 7 days late, 5% of the total marks available shall be deducted from the mark achieved. Where work is submitted up to and including 14 days late, 10% of the total marks available shall be deducted from the mark achieved. Work submitted 15 days late or more shall be assigned a mark of zero.
Pass Standard and any Special Requirements for Passing Module: 40%.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: Marks in passed element(s) of Continuous Assessment are carried forward, Failed element(s) of Continuous Assessment must be repeated (as prescribed by the School of Pharmacy).

University College Cork

Coláiste na hOllscoile Corcaigh

College Road, Cork T12 K8AF

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