Bio-pharmaceuticals are complex products and to ensure batch-to-batch consistency and product quality, analytical testing is required in advance of releasing the product to market. These tests ensure the products identity, integrity, purity and activity. This programme provides participants with an overview of the Quality Control function (QC), the test methods and the regulatory requirements in relation to QC in a bio-pharmaceutical manufacturing environment.
Aims and Objectives
The aim of this course is to provide learners with an essential understanding of the function of quality control within biopharmaceutical manufacturing, and how this relates to the manufacture of bio-pharmaceutical products. On completion of the programme learners will be able to demonstrate knowledge of quality control regulatory requirements, cGMP, QC test methods, laboratory information systems and typical QC standard operating procedure documentation.
Course Content
Introduction to QA and QC in an bio-pharmaceutical context
QC and validation
QC Chain of Custody
QC test methods and procedures
Accuracy, precision and reliability
cGMP compliance for healthcare products and bio-pharmaceuticals
Learning Outcomes
On completion of this programme the learner should be able to:
- Identify the regulatory bodies which oversee biopharmaceutical manufacturing
- Describe the relationship between Quality Control (QC) and Quality Assurance (QA) learning works
- Demonstrate an understanding of an organisation’s regulatory requirements related to QC
- Identify the key components of SOPs in relation to QC documentation
- Describe the principles of validation
- Demonstrate an understanding of the principles of QC test method and understand the importance of the QC chain of custody
- Describe the standard QC test methods
- Understand the concepts of accuracy, precision and reliability in QC testing
Other courses options include
On completion of this programme learners will be able to:
- 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 cGMP for the Bio-Pharmaceutical Manufacturing
- Introduction to Validation for the Bio-Pharmaceutical Sector
- Certificate in Supply Chain (Special Purpose Award/QQI Level 6 20 credits)
- Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 25 credits)
