Fundamentals of pharmaceutical manufacturing technologies

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Reference no: EM133770040

Fundamentals of Pharmaceutical Manufacturing Technologies TU Dublin Course Code: VOMP3001 Essay "Why Validation is Required for the Manufacture of a Medicinal Product" Candidate Name: Class: Date: Assignment Instructions: This is a 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

Reference no: EM133770040

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