TECHNOLOGICAL UNIVERSITY DUBLIN

TALLAGHT CAMPUS

Certificate

Pharmaceutical Medical Device Operations

Minor Award

Semester May 2018

LEVEL 6 Quality Assurance & GMP

Exam
Internal Examiners:
Dr. Teri Donaghy

External Examiners:

Day:
Date:
Time:

Instructions to Candidates:
Section A – Compulsory
Section B – Answer any two out of three questions
 SECTION A

Question 1 Compulsory (40 Marks)

Question 1 – Answer all questions (4 marks per question)

Q1. Who are the FDA and what is their purpose?

Q2. List the four components of a Quality Manual.

Q3. List the types of audit that occur in a GMP facility.

Q4. List the four phases of validation.

Q5. Explain two risks of poor GMP practices in the pharma industry .

Q6. Explain the term “SOP”.

Q7. List four types of document you would expect to find in a GMP
environment.

Q8. What is a “validation master plan”?

Q9. List four requirements for storage areas in a pharmaceutical

company.
Q10. What does the term “CAPA” mean?
 Section B – Answer any two out of three questions

Question 2 – Answer all sections (30 marks).

i) Define the term “fit for its intended use” when describing a
medicinal product (5 marks)
ii) Give five reasons why change control is important in a GMP
environment (10 marks)
iii) List and explain the five principles of GMP. (15 marks)

Question 3 – Answer all sections (30 marks).

i) What is tested in a typical QC laboratory in pharmaceutical

company? (6 marks)
ii) With the aid of a diagram, describe the relationship between
QA, GMP and QC. (12 marks)
iii) Explain the importance of a training program in a GMP
environment and explain three types of employee training.
(12 marks)

Question 4 – Answer all sections (30 marks).

i) List three reasons for calibrating a measurement device.

(6 marks)
ii) Explain the types of “process validation” approaches found in a
pharmaceutical environment. (12 marks)
iii) Explain in detail the purpose of a stability program for a
medicinal product and include in your answer a description of
two types of stability program. (12 marks)