Current Good Manufacturing Practice, also known as cGMP, is a set of regulations that ensure the quality of biotechnology products, pharmaceutical products, medical devices, food and beverage, and dietary supplements. The programme will provide learners with essential knowledge of the key concepts of cGMP within a bio-pharmaceutical context. Key topics include the regulatory requirements, the importance of cGMP and quality management across different business functions.
Aims and Objectives
This programme aims to provide learners with the core knowledge of cGMP in a bio-pharmaceutical manufacturing environment. On completion of the programme learners will be able to demonstrate knowledge of quality management systems, industry regulatory requirements, validation, documentation, contamination control and manufacturing technologies.
Course Content
What is a bio-pharmaceutical product
Origin and history of cGMP regulations
Quality Management System (QMS)
GDP - Good Documentation Practices
Introduction to validation
Product contamination and the associated risks
GLP - Good Laboratory Practices
Micro-organisms and biopharmaceuticals
Learning Outcomes
On completion of this programme the learner should be able to:
- Understand the terminology associated with cGMP and the regulatory requirements for working in this environment
- Identify the essential knowledge related to relevant legal, quality and regulatory frameworks governing the manufacture of bio-pharmaceutical products learning works
- Describe the elements of quality management systems in the context of bio-pharmaceutical manufacturing
- Describe the basic principles associated with validation
- Understand the technologies associated with the production of bio-pharmaceutical products
- Describe the sources of contamination and the risks associated with product contamination
Other courses options include
- Introduction to Technical Writing for the Manufacturing Sector
- Advanced Technical Writing for the Manufacturing Sector
- Introduction to Clinical Trials for the Pharmaceutical Sector
- Introduction to Validation for the Pharmaceutical Sector
- Introduction to Quality Control for Bio-Pharmaceutical Manufacturing
- Certificate in Supply Chain (Special Purpose Award/QQI Level 6 20 credits)
- Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 25 credits)
