PF6607: Pharmaceutical Process Design and Verification

Credit Weighting: 5
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semester 2.
Teaching Methods: 6 x 3hr(s) Lectures (lectures / workshops - blended learning); 50hr(s) Directed Study; 32hr(s) Other (self directed study)
Module Co-ordinator: Prof Abina Crean, School of Pharmacy.
Lecturer(s): Staff, School of Pharmacy.
Module Objective: To provide students with an introduction to the principles of pharmaceutical process design and validation.
Module Content: Risk assessment and quality by design. Equipment requirements and finishes. Scope and types of validation strategies, DQ, IQ, OQ, PQ concepts, Commissioning, Process verification, Cleaning validation, Analytical validation, Process automation and validation of process control systems (GAMP). Continuous process verification.
Learning Outcome: On successful completion of this module, students should be able to:
  • Explain the principles of quality by design and risk assessment
  • Explain the concepts of pharmaceutical validation strategies
  • Describe approaches to validation throughout the pharmaceutical life cycle
  • Design and discuss a qualification and/or validation document.
Assessment: Total Marks 100: Continuous Assessment 100 marks (3 x 1,000-1,500 word written assignments, 33.3 marks each).
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: 50%.
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).

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