To develop students competency in identifying, interpreting and applying cGMP guidelines and healthcare/pharmaceutical regulations, specifically within the Quality Control area and give them an understanding of sampling and some analytical methods.
Introduction to Manufacturers of Medical Devices, Healthcare Products and Pharmaceuticals
Manufacturers and Markets: Review of the types of the manufacturing companies and types of products which are manufactured in Ireland.
GMP Compliance for Healthcare Products and Pharmaceuticals
International regulatory agencies and the ICH. Case studies of events that directly impacted on the industry and regulatory agencies. Globalisation of the pharmaceutical sector; implications for control of the industry.
Quality Control in Manufacturing
Role of Quality Control. Organisation of QC Departments and role. Regulatory agencies, GMPs and documents, records and forms. GMP Lab compliance. Review of the typical structure of QC SOP.
QC Testing
Sampling: OC curves, sampling plans, sampling tables.The QC testing pathway. Review of commonly used QC tests. Materials Management, Raw material, Component and Product Identification etc.
Managing Quality
Product Status: Hold, Reject, In-Process, Release. Non-conformance reporting of defect products. Management of raw test data. Out of Specification (OOS) Investigations.
Analysis
Sample Preparation, Indicative SamplingGeneral Spectroscopy - General principles of Spectroscopy - properties of light, absorption and emission of light, quantitative laws, instrumentation - Ultra Violet-Visible Spectroscopy - Infrared Spectroscopy Atomic Spectroscopy Chromatographic methods – HPLC, GC
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |