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Essential Skills for Manufacturing in the (Bio)Pharmaceutical Industry 

Learners will develop key essential knowledge to in the areas of product quality, quality management systems, regulatory compliance, pharmaceutical manufacturing process steps, biopharmaceutical manufacturing process steps, risk management, QC testing, stability studies, deviation management and review future trends for the sector. 

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Description

Learner Profile:

Candidates who wish to develop a career within the Pharmaceutical/Biopharmaceutical industry. 

Candidates within the Pharmaceutical/Biopharmaceutical industry who wish to upskill and gain a wider understanding of the sector.   

Learner prerequisites:

Learners should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and English). 

Learning outcomes:

Learners will develop key essential knowledge to in the areas of product quality, quality management systems, regulatory compliance, pharmaceutical manufacturing process steps, biopharmaceutical manufacturing process steps, risk management, QC testing, stability studies, deviation management and review future trends for the sector.

Course Content:

Day 1: Introduction to Pharmaceutical and Biopharmaceutical Manufacturing


Module 1.1: Overview of Manufacturing



  • Role in the Industry



  • Types of Manufacturing: Primary & Secondary



  • Key Players and Their Facilities


Module 1.2: Regulatory Landscape in Manufacturing



  • Good Manufacturing Practices (GMP)



  • Regulatory Authorities: HPRA, FDA, EMA



  • Compliance and Audits


Module 1.3: Manufacturing Terminology



  • Glossary of Key Terms



  • Understanding Industry Jargon


Day 2: Principles of Pharmaceutical Manufacturing


Module 2.1: Raw Material Sourcing and Handling



  • Sourcing Guidelines



  • Quality Control of Raw Materials



  • Material Safety Data Sheets


Module 2.2: Production Lines and Process Flow



  • Overview of Equipment and Machinery



  • Batch Processing vs Continuous Processing



  • Workflow Optimization and Bottleneck Management


Module 2.3: Packaging and Labelling



  • Packaging Materials and Technologies



  • Labelling Requirements and Regulations



  • Packaging Integrity and Quality Assurance


Day 3: Principles of Biopharmaceutical Manufacturing


Module 3.1: Cell Culture and Fermentation



  • Introduction to Cell Lines



  • Bioreactors and Fermentation Tanks



  • Process Parameters and Optimization


Module 3.2: Purification and Filtration



  • Chromatography Techniques



  • Ultrafiltration and Diafiltration



  • Ensuring Product Purity and Quality


Module 3.3: Fill and Finish



  • Aseptic Filling Techniques



  • Lyophilization and Liquid Filling



  • Final Product Inspection and Release


Day 4: Quality Assurance, Control, and Risk Management in Manufacturing


Module 4.1: Quality Assurance (QA) in Manufacturing



  • Role of QA in Manufacturing



  • Development and Implementation of SOPs



  • Handling Deviations and Change Control


Module 4.2: Quality Control (QC) and Testing



  • In-process Controls and Testing



  • Finished Product Testing



  • Stability Studies and Shelf-Life Determination


Module 4.3: Risk Management in Manufacturing



  • Identification and Assessment of Risks



  • Implementation of Risk Mitigation Strategies



  • Continuous Monitoring and Improvement



Day 5: Opportunities, and Challenges in Pharmaceutical/Biopharmaceutical Manufacturing


Module 5.1: Industry Trends and Challenges



  • Emerging Technologies in Manufacturing



  • Sustainability and Environmental Considerations



  • Addressing Manufacturing Challenges


Module 5.2: Career Paths in Pharmaceutical Manufacturing



  • Overview of Various Roles: Operators, Supervisors, Engineers, Managers



  • Skills and Qualifications



  • Career Development and Progression

Duration:

25 hours

Exam/Continuous Assessment details:

Short Exercise/Quiz 

Certification /Awarding Body/Credits:

Vendor Certificate of Completion

Progression Pathway:

  • Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 – 25 Credits) (AMC22150) or

  • Certificate in Supply Chain Operations (Special Purpose Award/QQI Level 6 – 25 Credits) (AMC22151) or

  • Certificate in Pharmaceutical and Medical Devices Operations (QQI Minor Award Level 6)