Module Overview

Pharm Regulations, QA and Validation

In this module, students are introduced to the principles of quality assurance, process control and validation in the pharmaceutical and chemical industries. Context-based learning in small groups will give the students the opportunity to apply their knowledge to various real-world scenarios. Students assume the role of employees in a pharmaceutical manufacturing facility/testing laboratory working as part of cross-functional teams to deliver a new product. Active learning is promoted through student collaboration, problem solving and the use of case studies

Module Code

CHEM 3016

ECTS Credits


*Curricular information is subject to change



Pharmaceutical Regulations & Quality Assurance

Quality Management Systems including ISO standardsGood Manufacturing Practice GuidelinesRelationship between GMP and ValidationStatistical process control and process capabilityLean Manufacturing


Process ValidationCleaning ValidationAnalytical Method ValidationEquipment Qualification

Students will learn through lectures, workshops, online resources and site visits. Self-directed learning is encouraged.

Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)100