Section A Learning Objective This individual summative assessment will test your understanding of multiple aspects of drug development, testing and registration as it applies to the health products industry. This assessment has three components that will test your ability to apply good clinical practice principles to research in humans, to apply good manufacturing practice principles in product dynamics and to describe intellectual property and regulatory laws pertaining biological products. Project Topic You will be submitting a dossier to the South African regulatory authority, South African Health Product's Regulatory Authority (SAHPRA), for the production, clinical testing and patent registration of a nutraceutical product of your choice in South Africa. You will complete these "mock" applications for production site approval, ethics and patent registration. Scope This is an individual project with three components: Process Validation Protocol: choose a step in the production of your nutraceutical and describe a protocol for how to validate this production step of the nutraceutical. 1. Choose a nutraceutical active ingredient and brand name. 2. Decide whether your product will be a tablet, capsule, injectable or other formulation. (This will determine the most appropriate sections and content to include in your validation protocol). 3. Choose a company name and facility location. 4. To make your validation protocol complete and accurate: a. Decide whether you will be performing prospective, retrospective or concurrent validation. b. Research the equipment and processes required in the production of your chosen product. c. Choose a single process, list all the essential equipment, and brainstorm acceptable criteria and parameters for the validation testing of the process. d. Draft your protocol according to the templates provided in the Appendices.