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| Section | Weight | Objectives |
|---|---|---|
| Materials Systems | 13%-17% | - Material controls
|
| Quality Management Systems | 22%-26% | - Quality systems
|
| Packaging and Labeling Systems | 5%-9% | - Packaging controls
|
| Laboratory Systems | 10%-14% | - Laboratory operations
|
| Production Systems | 23%-27% | - Manufacturing operations
|
| Facilities and Equipment Systems | 18%-22% | - Equipment
|
1. Handling utensils for dispensing materials should be:
Response:
A) Chosen by the manufacturing staff based on personal preference
B) Color-coordinated with the product
C) The most expensive to ensure quality
D) Selected and managed according to the type of material and manufacturing process
2. Revalidation of processes is NOT typically required when:Response:
A) The product design is slightly altered for marketing purposes
B) There are significant changes to the process
C) New equipment is introduced
D) Regulatory guidelines change
3. When reviewing records such as logbooks and tags, what principle does NOT align with the ALCOA guidelines for data integrity?
Response:
A) Contemporary.
B) Attributable.
C) Original.
D) Legible.
4. The purpose of compendial methods in the testing of pharmaceuticals is to:
Response:
A) Reduce the need for regulatory oversight in pharmaceutical manufacturing.
B) Create a competitive advantage for certain pharmaceutical companies.
C) Ensure that all testing is done in the least amount of time possible.
D) Provide a standardized approach to testing for quality, safety, and efficacy.
5. Change control for equipment in the pharmaceutical industry ensures:
Response:
A) That equipment can be easily swapped out for newer models
B) A diversity of equipment colors to enhance employee morale
C) The equipment matches the latest fashion trends
D) Continual compliance and maintenance of the equipment's qualified state
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: A | Question # 3 Answer: A | Question # 4 Answer: D | Question # 5 Answer: D |
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