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Pharmaceutical Manufacturing Troubleshooting

Description: This quiz covers various aspects of troubleshooting in pharmaceutical manufacturing, including common issues, root cause analysis, and corrective actions.
Number of Questions: 15
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Tags: pharmaceutical manufacturing troubleshooting quality control process optimization
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Which of the following is a common issue encountered during tablet manufacturing?

  1. Capping

  2. Lamination

  3. Picking

  4. Sticking


Correct Option: A
Explanation:

Capping is a defect in tablet manufacturing where the top or bottom of the tablet separates from the rest of the tablet.

What is the primary cause of capping in tablet manufacturing?

  1. Insufficient compression force

  2. Improper formulation

  3. Defective tooling

  4. Incorrect tablet shape


Correct Option: A
Explanation:

Insufficient compression force during tablet manufacturing can lead to capping, as the tablet is not adequately compacted.

Which analytical technique is commonly used to evaluate the uniformity of tablet dosage forms?

  1. High-performance liquid chromatography (HPLC)

  2. Gas chromatography (GC)

  3. X-ray diffraction (XRD)

  4. Weight variation analysis


Correct Option: D
Explanation:

Weight variation analysis is a quality control procedure used to assess the uniformity of tablet dosage forms by measuring the individual weights of a representative sample of tablets.

What is the purpose of conducting a root cause analysis in pharmaceutical manufacturing troubleshooting?

  1. To identify the underlying cause of a problem

  2. To assign blame for the problem

  3. To document the problem for future reference

  4. To implement corrective actions without understanding the root cause


Correct Option: A
Explanation:

The primary objective of conducting a root cause analysis is to identify the underlying cause of a problem in order to prevent its recurrence.

Which of the following is a common corrective action taken to address the issue of capping in tablet manufacturing?

  1. Increasing the compression force

  2. Adjusting the formulation

  3. Replacing the tooling

  4. Changing the tablet shape


Correct Option: A
Explanation:

Increasing the compression force is a common corrective action taken to address capping in tablet manufacturing, as it helps to ensure adequate compaction of the tablet.

What is the primary objective of process validation in pharmaceutical manufacturing?

  1. To ensure that the manufacturing process consistently produces products that meet quality standards

  2. To optimize the manufacturing process for efficiency

  3. To reduce the cost of manufacturing

  4. To comply with regulatory requirements


Correct Option: A
Explanation:

The primary objective of process validation is to demonstrate that the manufacturing process consistently produces products that meet predetermined quality standards.

Which of the following is a common issue encountered during the manufacturing of sterile injectables?

  1. Particulate matter contamination

  2. Microbial contamination

  3. Pyrogen contamination

  4. All of the above


Correct Option: D
Explanation:

Particulate matter contamination, microbial contamination, and pyrogen contamination are all common issues encountered during the manufacturing of sterile injectables.

What is the purpose of conducting a risk assessment in pharmaceutical manufacturing?

  1. To identify potential hazards and assess their risks

  2. To develop and implement control measures to mitigate risks

  3. To document risks for future reference

  4. All of the above


Correct Option: D
Explanation:

The purpose of conducting a risk assessment in pharmaceutical manufacturing is to identify potential hazards, assess their risks, develop and implement control measures to mitigate risks, and document risks for future reference.

Which of the following is a common issue encountered during the manufacturing of solid oral dosage forms?

  1. Weight variation

  2. Content uniformity

  3. Dissolution problems

  4. All of the above


Correct Option: D
Explanation:

Weight variation, content uniformity, and dissolution problems are all common issues encountered during the manufacturing of solid oral dosage forms.

What is the primary objective of quality control in pharmaceutical manufacturing?

  1. To ensure that products meet predetermined quality standards

  2. To optimize the manufacturing process for efficiency

  3. To reduce the cost of manufacturing

  4. To comply with regulatory requirements


Correct Option: A
Explanation:

The primary objective of quality control in pharmaceutical manufacturing is to ensure that products meet predetermined quality standards.

Which of the following is a common issue encountered during the manufacturing of liquid oral dosage forms?

  1. pH variation

  2. Viscosity problems

  3. Microbial contamination

  4. All of the above


Correct Option: D
Explanation:

pH variation, viscosity problems, and microbial contamination are all common issues encountered during the manufacturing of liquid oral dosage forms.

What is the purpose of conducting stability studies in pharmaceutical manufacturing?

  1. To assess the stability of drug products over time

  2. To determine the shelf life of drug products

  3. To identify potential degradation pathways

  4. All of the above


Correct Option: D
Explanation:

The purpose of conducting stability studies in pharmaceutical manufacturing is to assess the stability of drug products over time, determine the shelf life of drug products, and identify potential degradation pathways.

Which of the following is a common issue encountered during the manufacturing of topical dosage forms?

  1. Skin irritation

  2. Allergic reactions

  3. Microbial contamination

  4. All of the above


Correct Option: D
Explanation:

Skin irritation, allergic reactions, and microbial contamination are all common issues encountered during the manufacturing of topical dosage forms.

What is the primary objective of good manufacturing practices (GMP) in pharmaceutical manufacturing?

  1. To ensure that products are manufactured in a consistent and controlled manner

  2. To minimize the risk of contamination and errors

  3. To comply with regulatory requirements

  4. All of the above


Correct Option: D
Explanation:

The primary objective of good manufacturing practices (GMP) in pharmaceutical manufacturing is to ensure that products are manufactured in a consistent and controlled manner, minimize the risk of contamination and errors, and comply with regulatory requirements.

Which of the following is a common issue encountered during the manufacturing of parenteral dosage forms?

  1. Particulate matter contamination

  2. Microbial contamination

  3. Pyrogen contamination

  4. All of the above


Correct Option: D
Explanation:

Particulate matter contamination, microbial contamination, and pyrogen contamination are all common issues encountered during the manufacturing of parenteral dosage forms.

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