This module aims to provide the student with the knowledge and practical skills of good manufacturing practice in the pharmaceutical regulated industries.
Quality Systems
ISO 9001, ISO 17025, Just in Time, lean manufacturing, six sigma, continuous improvement, operational excellence, lab accreditation, 5S, DMAIC model, FMEA
Regulatory Compliance
European and US regulatory controls, Regulatory bodies, auditing, ICH, Pharmacopieas, counterfeit medicines
GMP Documentation
Standard Operating Procedures, records and logbooks, batch records, manufacturing records, calibration records, maintenance logbooks, production area design, SOPs, out of specification, deviations, calibration, change control, stability trial, training requirements, good distribution practice
Validation
Validation plan and protocols. Process, equipment, utility, analytical method, cleaning, sterilisation, automation system validation.
Regulatory Affairs
Marketing application routes in Europe and US for new medicinal products
Bioethics
Bioethical issues, regulation
Bioinformatics
LIMs
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |