CTD Challenges Diagnostic Survey

1. How many years of experience do you have in Regulatory Affairs?

2. Which country are you currently working in?

3. What is your actual level of involvement in CTD dossiers?

I have not participated in preparing a complete dossier

I have only collected and arranged documents

I have contributed to writing some sections

I have reviewed Module 3 or other technical sections

I have prepared and reviewed a complete dossier

4. Have you previously attended a CTD course?

Yes, more than once

I attended a course but have not applied it to a real dossier

5. For participants who have previously attended a CTD course: After completing the course, were you able to independently prepare and review a CTD dossier?

☐ Yes, I was able to prepare and review a complete CTD dossier independently.

☐ Partially; I was able to arrange the dossier and prepare some sections, but I still needed support with technical sections.

☐ No; the course mainly covered the CTD structure and section requirements, but did not sufficiently cover the technical data behind the dossier.

☐ No; I understood where documents should be placed, but I could not determine whether the technical content was scientifically adequate.

☐ No; I still needed support from R&D, Production, QC, or QA to review and assess the submitted documents.

☐ I have not yet had the opportunity to apply what I learned to a real CTD dossier.

6. When you receive a document from R&D, QC, or Production, what do you review first?

Document title, version number, date, and signatures

Whether it is placed in the correct CTD section

The technical content and scientific logic within the document

Its consistency with other dossier documents

I need to consult the technical department before deciding whether it is acceptable

7. Which situation represents the greatest challenge when reviewing a dossier?

The document exists, but I cannot determine whether its technical content is sufficient

Conflicting information between different departments

Difficulty writing a convincing scientific justification

Understanding why a formulation or manufacturing process was selected

Evaluating validation or stability results

Converting technical information into a coherent CTD narrative

8. If test results are within specification, do you consider the document suitable for submission?

Yes, as long as the results passed

Usually yes, after reviewing the document format

Not always; the trend, test method, and relationship to the process must also be evaluated

I cannot decide without consulting QC or R&D

9. When there is a discrepancy between the Master Formula, Manufacturing Process, and Finished Product Specification, what is most difficult for you?

Detecting the discrepancy

Understanding the technical reason behind it

Determining which information is correct

Identifying which department should respond

Assessing the impact on more than one CTD section

10. Process Validation was performed on one pilot batch of 20,000 tablets, while the proposed commercial batch size is 200,000 tablets. The report also does not define the Critical Process Parameters or the IPC limits. How would you evaluate this?

The document is acceptable because the pilot batch results passed

The document is acceptable if the finished product results comply with specification

The document is insufficient; batch-size representativeness, number of validation batches, Critical Process Parameters, IPC limits, and their relationship to CQAs must be assessed

I cannot decide without consulting QA or Production

11. Three months of stability data were submitted to support a 24-month shelf life. What is the most difficult part of evaluating this situation?

Knowing the required duration of data

Understanding the trend rather than relying only on Pass/Fail

Linking the packaging and storage conditions to the results

Determining what may be submitted and what requires a commitment

12. If the Development Report only states the final formulation without explaining why the components and quantities were selected, would you consider it sufficient?

Yes, because the formulation is included

Yes, if the final results comply

No; Pharmaceutical Development should explain the rationale, trials, and relationship to product performance

13. Which skill would most improve your ability to work effectively on CTD dossiers?

Memorizing the CTD structure and section numbers

Obtaining a complete CTD template

Understanding how R&D, Production, QC, and QA work and how their outputs relate to the dossier

Training only on CTD writing

Training on document review and identifying technical deficiencies

14. Which topic would you most like to understand practically so you can work on CTD dossiers with confidence?

Pharmaceutical Development

Formulation and Manufacturing Process

Specifications and Analytical Methods

Process Validation

Integration of all departments within Module 3