Assignment Directions In this course, you will write a paper in which you take a novel drug (my topic is: A new novel drug: Monoclonal Antibodies for Treating Parkinson′s) and follow it through many stages. Starting with your own design concept, you will then consider its risks, lay out the facility space, map the manufacturing process, identify its test points, plan the validation activities, and identify key documents for the manufacturing and testing of your new product. For this project, your job is to propose a plan to manage how you envision your product could materialize into the company’s next new product. Your company’s management team is looking for a plan that is organized, well-vetted, feasible, and meets the applicable GMP regulations for your product. You only have up to 20 pages to demonstrate to them that your product is ready to move from concept to reality with a defined plan for its manufacture and testing. Following the outline provided below and the page length recommendations, prepare your report for management and convince them that your project is ready to move forward. Section 1: Executive Summary (1 page) Section 2: Product Desсrіption (2 pages) including: Intended Use / Clinical Indications Scientific principles Final formulation Section 3: Product Classification Desсrіption (1 page) in which you: specify the product classification, identify the governing FDA Center, list the governing US FDA regulations, list the relevant guidance documents for design, manufacture, and testing. Section 4: Facility Desсrіption (1 page) Section 5: Manufacturing and Testing Discussion (4 pages) Section 6: Validation Strategy (2 pages) Section 7: Risk Summary – outline top risks for your product and how you plan to address (1 page) Section 8: Appendixes Appendix A – Facility Floor Plan (1 page) Appendix B – Manufacturing and Testing Flow Diagram including test points, methods, and specifications (2 pages) Appendix C – List of Key Product Documents (1 page) Appendix D – Draft Certificate of Analysis (1 page) Section 9: References This Final Project Needs to be turned in using Turnitin, a plagiarism checking program. There is information about Turnitin on the syllabus. Here is more information about getting help with the Turnitin tool (Links to an external site.). Assignment Details Word document Length: 15- 20 pages 10-point font, Arial Double-spaced ALA Format Book we are to refer to is Biotechnology Operations Principles and Practices by John Centanni
