1. What is Developmental Quality Assurance (DQA)?
A:
Developmental Quality Assurance ensures that quality is built into a product during its development stages. It involves reviewing documents, processes, and protocols to meet regulatory and quality standards throughout the development lifecycle.

Q2. What is the role of DQA in pharmaceutical development?
A:
The role of DQA includes:

• Reviewing and approving development protocols.
• Ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Monitoring stability studies and product design.
• Ensuring regulatory documentation is accurate and complete.

Q3. How does DQA differ from regular Quality Assurance?
A:
DQA focuses on quality during the development phase, ensuring that all studies and processes are designed for compliance. Regular QA ensures quality during manufacturing and post-production processes.

Q4. Which guidelines are commonly followed in DQA?
A:

• ICH Guidelines (e.g., Q8 for pharmaceutical development, Q9 for quality risk management).
• WHO Guidelines for good practices in development.
• Local regulatory guidelines, such as those by FDA or EMA.

Q5. What is ICH Q8, and why is it important?
A:
ICH Q8 provides guidance on pharmaceutical development, focusing on Quality by Design (QbD). It helps ensure the product meets the desired quality attributes through a thorough understanding of formulation and manufacturing processes.

Q6. What types of documents are handled in DQA?
A:
Key documents include:

• Development protocols and reports.
• Risk assessment and mitigation plans.
• Stability study reports.
• Validation protocols and reports.

Q7. How would you ensure that a development protocol is compliant?
A:
I would:

• Cross-check against regulatory guidelines and internal SOPs.
• Review for completeness, clarity, and accuracy.
• Verify that the objectives, methods, and acceptance criteria are well-defined.

Q8. What is risk management in pharmaceutical development, and how is it applied?
A:
Risk management identifies, evaluates, and mitigates risks during product development. It is applied through tools like FMEA (Failure Mode and Effects Analysis) to prioritize potential risks and ensure robust processes.

Q9. How would you work with cross-functional teams during product development?
A:
Collaboration involves:

• Regular meetings to discuss progress and challenges.
• Sharing and reviewing documents promptly.
• Ensuring all teams understand quality expectations and regulatory requirements.

Q10. If a stability study report shows a borderline out-of-specification (OOS) result, what steps would you take?
A:

1. Verify the result to ensure no errors in testing or documentation.
2. Investigate the cause by reviewing the protocol and testing methods.
3. Escalate the issue to the supervisor and recommend a detailed root cause analysis.
4. Propose corrective and preventive actions (CAPA) to avoid recurrence.

Q11. How do you stay updated on pharmaceutical quality assurance guidelines?
A:
I regularly review guidelines from ICH, WHO, and regulatory authorities like FDA. I also follow industry webinars, online courses, and scientific journals.

Q12. Describe a time when you had to ensure the quality of a process or product. How did you approach it?
A:
As a fresher, during my academic project, I ensured quality by strictly following SOPs, verifying experimental data, and reviewing reports with my mentor to meet project standards.

Q13. What is the importance of critical quality attributes (CQAs) in development?
A:
CQAs are physical, chemical, biological, or microbiological properties that must be controlled to ensure the product’s quality, safety, and efficacy. Identifying and monitoring CQAs helps achieve consistency during development and manufacturing.

Q14. Can you explain the concept of Design of Experiments (DoE)?
A:
DoE is a statistical method used to study the effects of multiple factors on a process. It helps optimize formulations and processes by identifying critical parameters and their interactions.

Q15. How would you approach drafting a validation protocol for a new analytical method?
A:
I would:

1. Define the scope and objective of the validation.
2. Specify the method’s critical parameters (e.g., accuracy, precision, linearity).
3. Include step-by-step procedures for testing.
4. Define acceptance criteria based on regulatory guidelines.