Dear Sir/Madam,
Please find attached the comments from Duopharma for your consideration.
Thank you.

1. Routine and For-Cause Inspection should be numbered
2. Flow chart 3.2- pre-inspection preparation - to rephrase to enhance clarity for e.g 'Submit pre-inspection documents?
3. Section 4.0- outcome of GCP inspection (favourable outcome and non-compliance) may need to be aligned with section 6.0. Critical, major and minor - how does it classified under favorable outcome or non-compliance
4. Pg 23 - Appendix A > clinical trials reviewed> should also include CTX
5. Pg 24-under the heading facilities and equipment -our inspection is not limited to this also protocol etc, perhaps the heading can be broader
6. Explanation in 'original' are great and should be considered to produce a comprehensive guidelines
7. Must have a clear statement 'inspection' conducted by regulatory authorities whereas 'audit' can be performed by others CRO, sponsors, study site etc

Dear NPRA,

1. The term CTIL/CTX is still in mentioned : line 740 and 741.

2. How about inspection towards Clinical Trial approved by MDA? As in safety of the patients uses the interventional medical devices but not in systemic or active compound?

3. inspected party (parties) like inspection can be at CRO , sponsor and site. or organizations . EMA uses personnel

4. Inspection report: Report prepared by the official representing the Competent Authority stating
whether the company inspected in general complies with the requirements of Directive (EU)
2017/1572, Delegated Regulation (EU) 2017/1569 and/or 91/412/EEC and whether the manufacturer
is acceptable for the products in question. The Union report format applies

5. CAPA reporting still has CTIL/CTX

6. How Clinical Trial Authorization (CTA) impacted in GCP onspection is that only based on the holders or site or CRO manages the trial.

Dear sir/madam,
Please find attached the comments from Hanan Regulatory Services.
Thank you

1. If there is evidence of serious breach of misconduct, will the investigator be blacklisted from conducting a trial?
2. It may be good to have the inspection checklist as an appendix.
3. How come there is no decision tree on whether DCA is going to terminate, suspend, or continue on the conduct of research?
4. Wll there be any clinical audit since it is a clinical matter? I mean there should be a doctor as part of the inspection team.