VOMP3001 Fundamentals of Pharmaceutical Manufacturing Technologies Assignment Essay
| University | Technological University Dublin (TUD) |
| Subject | VOMP3001 Fundamentals of Pharmaceutical Manufacturing Technologies |
VOMP3001Assignment Essay
“Why Validation is Required for the Manufacture of a Medicinal Product”
Assignment Instructions:
This is a 3,000-word essay overall supplemented with relevant diagrams. It should be focussed on proving that by following good validation practices in the manufacture of medicinal products, the medicines/vaccines/devices produced will consistently meet the Product Quality and Patient Safety standards of the FDA and other regulatory agencies.
See the 10 Big Ideas list below:
- Big Idea 1 – Overview of Medicinal Products Manufacturing
- Big Idea 2 – GMPs and Regulations
- Big Idea 3 – Quality Management Systems and their Key Enablers
- Big Idea 4 – Cost Effective Validation
- Big Idea 5 – GAMP & the Lifecycle of a Computerised System
- Big Idea 6 – Validation of Drug Substance Manufacturing
- Big Idea 7 – Validation of Drug Products Manufacturing
- Big Idea 8 – Validation of Medical Devices
- Big Idea 9 – Quality Risk Management Tools
- Big Idea 10 – Any Other Big Idea
You need to choose 4 big ideas out of the 10 for your essay. There are details about what you need to cover for each of the Big Ideas in the following pages.
You should write 600 words on each of the four Big Ideas that you choose, and also include a 300 word Introduction and a 300 word Conclusion.
Don’t forget to include your reference list / bibliography at the end, and relevant diagrams where appropriate.
Introduction – 300 words
Big Idea 1: Overview of Medicinal Products Manufacturing
What do I need to cover:
● (Major supporting point a) Medicinal Product Manufacturing – 300 words
Compare the outputs associated with the manufacturing sequence of drug substance, drug product, and finished products, and the various administration techniques associated with finished products including enteral, parenteral, and topical.
● (Major supporting point b) Key Product Quality Attributes and Process Parameters – 300 words
Identify key product quality attributes associated with the administration of enteral, parenteral, and topical products. Describe key process considerations and related validation activities associated with the manufacturing outputs of drug substance, drug product, and finished product.
Big Idea 2: GMPs and Regulations
What do I need to cover:
- (Major Supporting Point a) Good Manufacturing Practices – 300 words
Describe the content of a typical GMP, and identify some regulatory agencies that issue them (e.g. ISO, FDA, etc.). - (Major supporting point b) GMP Compliance Efficiencies – 300 words
Compare and contrast specific GMPs for the manufacture of drug substance versus finished product (e.g. ICH Q7 versus 21 CFR Part 211), and describe why regulatory authorities inspect pharmaceutical manufacturers’ compliance with relevant GMPs and validation documentation.
Big Idea 3: Quality Management Systems and their Key Enablers
What do I need to cover:
- (Major Supporting Point a) Quality Management Systems (QMS) – 300 words
Discuss the contents of a suitable QMS for the manufacture of medicinal products (e.g. ISO 9001, ISO 13485, ICH Q10, etc.) - (Major Supporting Point b) Key Enablers for a QMS – 300 words
Describe a ‘Product Realisation’ strategy that validates the alignment of design activities against specification activities, and discuss the business drivers for a QMS alongside the key enablers that make a QMS successful.
Big Idea 4: Cost Effective Validation
What do I need to cover:
- (Major Supporting Point a) Validation and the V-Model – 300 words
Describe the classic V-Model and how it aligns testing activities to specification documents, to confirm that the equipment being validated is fit-for-purpose
- (Major Supporting Point b) Cost Effective Validation – 300 words
Describe an efficient approach to ‘Validation’ driven by subject matter expertise and risk based decision making.
Big Idea 5: GAMP & the Lifecycle of a Computerised System
What do I need to cover:
- (Major Supporting Point a) Good Automated Manufacturing Practices – 300 words
Describe the GAMP®5 approach to validating computer systems that impact the manufacture of medicinal products. - (Major Supporting Point b) Product Lifecycle Activities – 300 words
In accordance with GAMP®5, explain typical product lifecycle activities for a control system across the ‘concept’, ‘project’, ‘operation’ and ‘retirement’ phases of a computerised system with respect to specification and validation activities.
Big Idea 6: Validation of Drug Substance Manufacturing
What do I need to cover:
- (Major Supporting Point a) Drug Substance Manufacturing – 300 words
Outline the manufacturing sequence for typical chemically derived Active Pharmaceutical Ingredients (API), and for typical Biopharmaceutical Protein Therapeutics. - (Major Supporting Point b) Validation of Drug Substance Manufacturing – 300 words
For a typical API and biopharmaceutical process, identify the key product quality attributes and associated process parameters to be validated.
Big Idea 7: Validation of Drug Products Manufacturing
What do I need to cover:
- (Major Supporting Point a) Drug Products Manufacturing – 300 words
Outline the manufacturing sequence for finished medicinal products such as tablets, vials, etc. - (Major Supporting Point b) Validation of Drug Products Manufacturing – 300 words
For typical finished product processes (e.g. tablets, vials, etc.), identify key product quality attributes and associated process parameters to be validated.
Big Idea 8: Validation of Medical Devices
What do I need to cover:
- (Major Supporting Point a) Medical Devices – 300 words
Describe the rules and guidelines for the manufacture of medical devices, the various classifications of medical devices (Class I, II and III), and give examples of each. - (Major Supporting Point b) Validation of Medical Devices – 300 words
Select any device in each of the major medical device categories and identify key product quality attributes and associated manufacturing process parameters to be validated.
Big Idea 9: Quality Risk Management Tools
What do I need to cover:
- (Major Supporting Point a) Quality Risk Management – 300 words
Discuss how science based decisions can be made using the 4-step risk management process below:
- Identify major risks with respect to product quality and patient safety.
- Evaluate and prioritize the list of faults.
- Decide what risks are currently acceptable, and subsequently decide on a suitable mitigation strategy(s) for priority risks.
- List a post-implementation review strategy that ensures both successful risk-mitigation strategy(s) and identifies any new risks.
- (Major Supporting Point b) Science Based Decision Making – 300 words
Discuss the merits of using a documented science based decision making process to identify priority specification and validation activities for any manufacturing/equipment system to ensure product quality and patient safety.
Big Idea 10 – Any Other Big Idea
Feel free to pick any other Big Idea covered in your course:
- (Major Supporting Point a) Any Other Topics – 300 words
Use your course content to support your big idea and how it relates to validation for the manufacture of safe medicines, vaccines and medical devices. - (Major Supporting Point b) Any Other Topics – 300 words
Use your course content to support your big idea and how it relates to validation for the manufacture of safe medicines, vaccines and medical devices
Conclusion – 300 words
References / Bibliography List:
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