This module will give you a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied along with the risk management tools to be used when making decisions that could impact the safety of the medicines being manufactured.
Week 1 – Manufacturing Safe Medicines
Week 2 – GMP’s and Quality Management Systems
Week 3 – Good Automated Manufacturing Practices (GAMP)
Week 4 – API Manufacturing Technologies
Week 5 – Biopharmaceutical Manufacturing Technologies
Week 6 – Cleaning Validation
Week 7 – Medical Devices and Sterile Manufacturing
Week 8 – PQ OQ IQ
Week 9 & 10 – Complete an End of Module Assignment. Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.
This course explains the engineering documentation used to specify and design equipment or systems in a manufacturing facility – and how to develop the test protocols (IQ, OQ, PQ) to ensure that it operates as intended and meets the regulatory requirements.
Week 11 – Interpreting P&ID’s
Week 12 – System Impact Assessment & Traceability Matrix
Week 13 – Installation Tests & Equipment Verification
Week 14 – Piping Isometrics & Checksheets
Week 15 – Instrument Loops & Checksheets
Week 16 – URS & Functional Testing
Week 17 – Assembling the Validation Protocol
Week 18 – Validation Protocol Final Review
Week 19 & 20 – Complete an End of Module Assignment. Write an IQ OQ PQ protocol for a Clean-in-Place system.
The aim of this module is to provide a foundation in the general chemistry necessary to appreciate the fundamental concepts involved in the chemistry of API (Active Pharmaceutical Ingredients) required for the manufacture of medicinal products.
Week 21 – Chemistry and Matter; Atomic Theory
Week 22 – The Periodic Table and Bonding
Week 23 – Stoichiometry
Week 24 – Acids and Bases Recrystallisation
Week 25 – Introduction to Organic Chemistry
You will need to complete a full day laboratory during the remaining 5 weeks of the module. We will release preparatory material before the lab for you to study, review and print out.
Note: Labs are always held on Saturdays at the Dublin Institute of Technology. Special arrangements will be made for non-Irish residents.
Week 26 – Release & Review Materials ahead of Attending Laboratories
Introduction to Practical Chemistry
Materials for Laboratory Part 1 – Synthesis of Aspirin
Materials for Laboratory Part 2 – Organic Compound
Materials for Laboratory Part 3 – Calculations
Materials for Laboratory Part 4 – Preparation of Sodium Carbonate for washing soda using Titration
Week’s 27 – 30+ Attending Laboratory and Completion of an Online Exam