In This Section
CM2012: Validation Science
| Credit Weighting: | 5 |
|---|---|
| No. of Students: | Min 10. |
| Pre-requisite(s): | |
| Co-requisite(s): | |
| Teaching Period(s): | Semester 2. |
| Teaching Methods: | 40 x 15min(s) Lectures (online); 4 x 3hr(s) Workshops (Industry led); 6 x 1hr(s) Other (Industry webinars); 6 x 1hr(s) Directed Study |
| Module Co-ordinator: | Dr Eric Moore, Department of Chemistry. |
| Lecturer(s): | Staff, Department of Chemistry, Industry Guest Speakers. |
| Module Objective: | This module gives the learner a broad understanding of the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical, biopharmaceutical and medical device industries. The use of risk assessment techniques in validation is explained. |
| Module Content: |
路 Validation Lifecycle EU and FDA regulations and guidelines. V-Model, introduction to the understanding-demonstration-monitoring approach. 路 Process Validation Quality by design, establishing a strategy for process control. Commissioning and qualification of processes and utilities. Process Performance Qualification Continued Process Verification. Prospective, concurrent and retrospective approaches in process validation. Revalidation. 路 Risk Management in Process Validation Review of industrially recognised risk management guidelines and application of tools such as PHA, FMECA and Fault Tree Analysis. 路 Validation of Pharmaceuticals and Biopharmaceuticals Validation of APIs, solid dosage forms, inhalation aerosols. Sterilisation and aseptic process validation. 路 Validation of Medical Devices Lifecycle approach to validation with a focus on medical devices. Validation vs. verification. Validation of software controlling a medical device. 路 Analytical Method Validation Review of the steps to prove that analytical methods are fit for purpose with reference to current guidelines. 路 Computer and Automation Validation Compliance with 21 CFR Part 11 and use of GAMP guidelines. Confirmation of data integrity. 路 Cleaning Validation Methodologies used to prove the effectiveness of equipment cleaning processes and procedures in the manufacturing process. 路 Validation Documentation Preparation and review of validation documents such as the User Requirement Specification, Validation Master Plan, Validation Protocol, Validation Report. |
| Learning Outcome: |
On successful completion of this module, students should be able to:
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| Assessment: | Continuous assessment: 4 x workshop assignments and 6 x online MCQ assessments. |
| Compulsory Elements: | Continuous Assessment. |
| Penalties (for late submission of course/project work etc.): | Work which is submitted late shall be assigned a mark of zero (or a Fail Judgement in the case of Pass/Fail modules). |
| Pass Standard and any Special Requirements for Passing Module: | A Pass judgement. |
| End of Year Written Examination Profile: | No Formal Written Examination. |
| Requirements for Supplemental Examination: | No Supplemental Examination. |