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Ollscoil na hÉireann, Gaillimh
National University of Ireland, Galway
Spring Examinations 2010 / 2011
Exam Code(s) 3BPC
Exam(s) Third Science Examination
Module Code(s) CH
Module(s) Industrial Chemistry and Validation
Paper No. Repeat Paper
External Examiner(s) Professor K. Molloy Internal Examiner(s) Dr. L. F. Jones Dr W. Carroll Dr B. O`Brien
Instructions: Answer 2 questions from Section A and 1 question from B
All questions will be marked equally Use separate books for Sections A and B
Duration 2 hours No. of Pages 4 Department(s) Chemistry Course Co-ordinator(s) Dr. L. F. Jones
Requirements : MCQ Handout Statistical Tables Graph Paper Log Graph Paper Other Material
Please use separate answer books for Sections A and B
Section A
Answer three (3) questions from this section.
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. [13 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. [ 12 marks]
2. Answer all parts
With respect to cleaning validation, explain the following points while highlighting
their importance with respect to the pharmaceutical / biopharmaceutical industry:
(a) Equipment to be cleaned [5 marks] (b) Personnel responsibilities [5 marks] (c) Sampling methods [5 marks] (d) Record keeping [5 marks] (e) The Establishment of Limits [5 marks]
3. Discuss what is meant by the term Process Analytical Technology (PAT) and describe its origin and objectives. [25 marks] 4. Discuss and explain the following terms in relation to the manufacturing of pharmaceuticals / bio-pharmaceuticals:
(a) Design Qualification (b) Installation Qualification (c) Operational Qualification (d) Performance Qualification [25 Marks]
Section B
You must answer this question:
6. Answer each of the following.
(a) Define “capital cost” and “production cost”. What are the important factors which affect capital cost and production cost in the chemical industry?
[9 marks]
(b) Outline the most important raw material sources for carbon based compounds in the chemical industry.
[8 marks]
(c) Which of the following are in the top five chemicals list for inorganic chemicals and organic chemicals respectively?
Inorganic: Cl 2 , NaOH, CsCl, H 2 SO 4 , NaF, NH 3
Organic: Analine, Urea, Ethene, Styrene, Ethylenedichloride, Asprin
[8 marks]
