Module Overview

Good Manufacturing Practice and Quality Systems

This module aims to provide the student with the knowledge and practical skills of good manufacturing practice in the pharmaceutical regulated industries.

Module Code

GMPR H3040

ECTS Credits


*Curricular information is subject to change

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 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


Bioethical issues, regulation



Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)30
Formal Examination70