Farmasi Industry Tutorial 2 (Dr.

Mazlina Mohd Said)

SECTION A

1. The basic requirements for GMP for the manufacture of medicinal products include:

A. Personnel must be highly qualified.

B. Operators are trained to carry out procedures correctly.

C. Operators should receive medical examination every six month.

D. Training should be conducted when needed.

E. All manufacturing equipment must be up-to-date.

2. The sentences below describe fitness for its purposes of medicinal products, EXCEPT:

A. It is correctly labeled.

B. It is free from contamination.

C. It has fewer side effects.

D. It is in the right container.

E. It is the right medicines.

3. A basic requirement for quality control is:

A. All samples must be tested before approved for distribution.

B. Quality control laboratory must be located inside the manufacturing area.

C. All test methods should be validated.

D. In process quality control need to be conducted by the manufacturing operators.

4. The adequate working space and in-process storage area should permit the orderly and logical positioning
of equipment and materials so as to:

i. to avoid cross contamination.

ii. minimize the risk of confusion between different medicinal products and their
components.

iii. minimize the risk of omission or wrong application of any of the manufacturing or
control steps.

iv. enable easy documentation of the process.

A. I only.
 B. I and II only.

C. II and III only.

D. I, II, and III only.

E. I, II, III, IV.

5. Product recall procedure should include the following details, EXCEPT:

A. who should be involved in evaluating the information.

B. how a recall should be initiated.

C. the total cost of recall materials.

D. who should be informed about the recall.

E. how the recall materials should be handled.

6. Any alteration to the entry on a document should:

i. be signed and dated.

ii. permit the reading of the original information.

iii. distribute a memo to related personnel informing the reason for alteration.

iv. be completed in pencil.

A. I only.

B. I and II only.

C. II and III only.

D. I, II, and III only.

E. I, II, III, IV.

7. An out of specification or significant de-trend in a manufacturing process:

i. should be investigated.

ii. will temporarily put the process on-hold.

iii. indicates the procedure needs to be changed.

 iv. should be reported to the relevant competent authorities.

A. I only.

B. I and II only.

C. II and III only.

D. I, II, and III only.

E. I, II, III, IV.

8. The objectives of Quality Management are to ensure products:

i. safety.

ii. quality.

iii. efficacy.

iv. cost-effectiveness.

A. I only.

B. I and II only.

C. II and III only.

D. I, II, and III only.

E. I, II, III, IV.

9. Specifications for the final finished products should include:

i. package details.

ii. the product name.

iii. shelf life duration .

iv. storage temperature requirement.

A. I only.

B. I and II only.

C. II and III only.

D. I, II, and III only.

E. I, II, III, IV.

10. On-line control of product during packaging should include at least checking the followings EXCEPT

A. over-printing.

B. correct functioning of line monitors.

C. completeness of the packages.

D. general appearance of the packages.

E. printed labels on the packages.

11. The system of Quality Assurance appropriate for the manufacturer of medicinal products should ensure
that:

A. managerial responsibilities are clearly specified.

B. the SOPs are being update monthly.

C. manufacturing instruments must be renewed every three years.

D. valid procedures for continuous staff assessment are available.

E. training must be validated.

SECTION B

1. Briefly explain the relationship between Quality Assurance, GMP and Quality Control (5 Marks)

Refer to lecture notes.

2. Design a label for a new pharmaceutical raw material under quality control testing (5 marks)