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Details about an exam for the m.sc. Biomedical science module bes515 at the national university of ireland, galway, during the spring examinations of 2009-2010. The exam covers topics related to product development, validation, and regulation. It includes information about the exam code, modules, paper number, duration, departments, course coordinators, and instructions. Questions include topics on manufacturing regulations, validation master plans, process analytical technology, cleaning validation, regulatory processes for combination products, and definitions of medical devices.
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Exam Code(s) 1MV
Exam(s) M.Sc. Biomedical Science
Module Code(s) BES
Module(s) Product Development, Validation and Regulation
Paper No. 1 Repeat Paper
External Examiner(s) Professor K. Molloy Internal Examiner(s) Professor P. V. Murphy Professor L. Eriksson Dr. Leigh Jones Instructions: Answer any three questions All question are marked equally Duration 2 hours No. of Pages 2 Department(s) Chemistry Course Co-ordinator(s) Dr. Niall Geraghty
Requirements : MCQ Handout Statistical Tables Graph Paper Log Graph Paper Other Material
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1. Answer all parts (a) With respect to manufacturing regulations, briefly describe what is meant by the term validation and discuss its origin and aims. [17 marks] (b) Manufacturers in the food and drug industries are not required by law to possess a Validation Master Plan (VMP) however the majority will have produced such a document. Discuss the advantages for creating such a dossier. [ 17 marks] 2. Discuss what is meant by the term Process Analytical Technology (PAT) and describe its origin and objectives. **[34 marks]