Advanced Questions and Answers on MS&T in Injectable Plants – Part 2

1. Troubleshooting and Continuous Improvement

Question: What approach do you follow to troubleshoot a batch failure?
Answer:

• Conduct a root cause analysis using tools like fishbone diagrams or 5 Whys.
• Review process parameters, batch records, and equipment logs.
• Evaluate environmental monitoring data and operator compliance.
• Implement corrective and preventive actions (CAPA) and revalidate the process if needed.

Question: How do you handle deviations during injectable manufacturing?
Answer:
Deviations are handled by:

• Documenting the deviation in detail.
• Performing an impact assessment on product quality.
• Implementing interim controls to prevent recurrence.
• Conducting a formal investigation and implementing CAPAs.

2. Equipment and Technology

Question: What is your experience with lyophilization in injectable manufacturing?
Answer:
Lyophilization requires expertise in cycle development, including freezing, primary drying, and secondary drying phases. I have worked on optimizing lyophilization parameters such as shelf temperature, chamber pressure, and hold times to ensure consistent product stability and moisture content.

Question: Explain how you ensure container closure integrity (CCI) in injectable production.
Answer:
CCI is ensured by:

• Performing validated testing methods such as helium leak detection or dye ingress tests.
• Ensuring proper setup and maintenance of sealing equipment.
• Regularly inspecting seals and closures for defects.
• Implementing robust controls for vial, stopper, and crimp compatibility.

3. Regulatory and Quality Compliance

Question: How do you ensure compliance with regulatory requirements in injectable manufacturing?
Answer:
Compliance is ensured by:

• Following cGMP guidelines and maintaining detailed documentation.
• Conducting periodic internal audits.
• Staying updated on regulatory changes and guidelines (e.g., FDA, EMA).
• Implementing a robust quality management system (QMS).
• Validating all processes and maintaining a state of control.

Question: What quality metrics do you monitor in an injectable plant?
Answer:
Common metrics include:

• Sterility assurance level (SAL).
• Endotoxin levels.
• Particle counts in finished products.
• Environmental monitoring data.
• Batch yield and deviation rates.

4. Teamwork and Leadership

Question: How do you handle cross-functional collaboration in MS&T?
Answer:
Collaboration involves:

• Regular meetings with R&D, QA, and production teams to align on goals.
• Sharing insights from manufacturing to optimize R&D processes.
• Ensuring all stakeholders are informed during technology transfer or troubleshooting.

Question: How do you foster a culture of continuous improvement in your team?
Answer:

• Encouraging team members to share suggestions and feedback.
• Using data-driven approaches to identify process inefficiencies.
• Providing training on new technologies and methods.
• Recognizing and rewarding innovative solutions.