MCQ About The Primary Packaging Section Of OSD Production

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#1. What is the primary purpose of the Primary Packaging Section in the OSD Production Plant of a pharmaceutical manufacturing facility?

a) To formulate the active pharmaceutical ingredient

b) To compress and form tablets or capsules

c) To package the final dosage forms into their immediate containers

d) To perform quality control testing on raw materials

#2. What is the primary objective of packaging in the OSD Primary Packaging Section?

a) To modify the therapeutic action of the drug

b) To extend the shelf life of the drug

c) To enhance the physical appearance of the drug

d) To protect the drug from external factors and ensure accurate dosing

#3. Which regulatory body's guidelines must be followed when designing and operating the Primary Packaging Section in a pharmaceutical manufacturing plant?

a) Food and Drug Administration (FDA)

b) World Health Organization (WHO)

c) European Medicines Agency (EMA)

d) International Organization for Standardization (ISO)

#4. What is a common material used for primary packaging of tablets and capsules to provide protection from moisture and light?

a) Glass containers

b) Aluminum foil

c) Cardboard boxes

d) Plastic drums

#5. Which aspect is of utmost importance when selecting primary packaging materials for pharmaceutical products?

a) Cost-effectiveness

b) Aesthetic appeal

c) Compatibility with the drug product

d) Ease of transportation

#6. What type of information is typically included on the packaging of pharmaceutical products in the Primary Packaging Section?

a) Manufacturing equipment specifications

b) Process parameters for API synthesis

c) Patient instructions and dosage information

d) Laboratory testing procedures

#7. What is the role of the Quality Control department in the Primary Packaging Section?

a) To operate the packaging equipment

b) To ensure proper labeling of packaging materials

c) To perform clinical trials on the packaged drugs

d) To maintain the cleanliness of the packaging area

#8. What is the purpose of conducting line clearance before starting the packaging process?

a) To ensure the packaging line operates at maximum speed

b) To ensure all packaging materials are available

c) To clean the packaging equipment

d) To record the temperature and humidity of the packaging area

#9. What key documentation must be maintained in the Primary Packaging Section to ensure traceability and regulatory compliance?

a) Patient testimonials

b) Packaging artwork designs

c) Equipment maintenance schedule

d) Batch records and packaging record

#10. What is the purpose of performing in-process checks during the packaging process in the Primary Packaging Section?

a) To ensure the packaging line operates at maximum speed

b) To reduce the cost of packaging materials

c) To monitor the quality of the packaging process and detect deviations

d) To expedite the packaging process to meet production targets

#11. In the context of blister packaging, what is a "blister pack"?

a) A machine used to print labels on pharmaceutical products

b) A container made of glass for storing tablets

c) A plastic sheet with molded pockets containing individual doses of medication

d) A cardboard box used for bulk packaging of tablets

#12. Which type of blister packaging is commonly used for protecting individual tablets or capsules?

a) Vial packaging

b) Strip packaging

c) Ampoule packaging

d) Bottle packaging

#13. What is the role of a "barrier film" in pharmaceutical blister packaging?

a) To prevent physical damage to the packaging

b) To provide clear visibility of the medication

c) To protect the contents from moisture, light, and gases

d) To enhance the shelf life of the medication

#14. Which quality control test is specifically performed in the Primary Packaging Section to ensure that tablets or capsules are accurately dosed?

a) Hardness testing

b) Friability testing

c) Weight variation testing

d) Dissolution testing

#15. What is the main goal of "serialization" in pharmaceutical packaging?

a) To enhance the visual appeal of the packaging

b) To improve the accuracy of dosing

c) To prevent counterfeiting and enhance traceability

d) To simplify the packaging process

#16. Which of the following aspects should be considered when designing packaging for a pharmaceutical product in the Primary Packaging Section?

a) Availability of raw materials

b) Compatibility with secondary packaging

c) Speed of the packaging line

d) Aesthetic appeal only

#17. What is the role of "batch coding" on pharmaceutical packaging in the Primary Packaging Section?

a) To indicate the expiry date of the product

b) To indicate the manufacturing date of the product

c) To enhance the product's flavor

d) To regulate the packaging line speed

#18. In the context of blister packaging, what is the formula to calculate the "Fill Efficiency"?

a) Fill Efficiency = (Actual number of tablets / Maximum number of tablets) × 100%

b) Fill Efficiency = (Maximum number of tablets / Actual number of tablets) × 100%

c) Fill Efficiency = (Tablet weight / Packaging weight) × 100%

d) Fill Efficiency = (Packaging weight / Tablet weight) × 100%

#19. What is the formula to calculate the "Yield" in the Primary Packaging Section?

a) Yield = (Number of defective units / Total number of units) × 100%

b) Yield = (Total number of units / Number of defective units) × 100%

c) Yield = (Number of acceptable units / Total number of units) × 100%

d) Yield = (Total number of units / Number of acceptable units) × 100%

#20. What is the formula to calculate the "Downtime Percentage" in the Primary Packaging Section?

a) Downtime Percentage = (Total production time / Total downtime) × 100%

b) Downtime Percentage = (Total downtime / Total production time) × 100%

c) Downtime Percentage = (Actual production time / Planned production time) × 100%

d) Downtime Percentage = (Planned production time / Actual production time) × 100%

#21. What is the formula to calculate the "Line Efficiency" in the Primary Packaging Section?

a) Line Efficiency = (Total planned production time / Total actual production time) × 100%

b) Line Efficiency = (Total actual production time / Total planned production time) × 100% b) Line Efficiency = (Total planned production time / Total actual production time) × 100%

c) Line Efficiency = (Total tablets produced / Maximum number of tablets) × 100%

d) Line Efficiency = (Maximum number of tablets / Total tablets produced) × 100%

Finish

MCQ about the Primary Packaging Section of OSD Production