sites.

3. Responsibilities

• Quality Assurance Head: Acts as the inspection coordinator and is responsible for audit readiness and response management.
• Principal Investigator: Responds to scientific and protocol-related queries during inspection.
• Clinical Trial Manager: Coordinates logistics, documentation, and access to study records.
• Document Control Officer: Provides controlled copies of requested documents and maintains tracking.

4. Accountability

The Site Director or Facility Head is accountable for ensuring successful inspection readiness, document availability, and compliance with all applicable regulatory standards.

5. Procedure

5.1 Pre-Inspection Preparedness

1. Maintain an inspection readiness checklist (Annexure-1) reviewed monthly by QA.
2. Ensure the Trial Master File (TMF) and Investigator Site File (ISF) are complete and updated.
3. Conduct mock audits every six months and document findings in Annexure-2: Mock Audit Report.
4. Ensure key staff are trained on GCP, protocol, SOPs, and inspection handling procedures.

5.2 Inspection Announcement

1. Upon notification of inspection:
   • Inform sponsor and QA immediately
   • Assign Inspection Coordinator and Support Team
   • Prepare Annexure-3: Inspector Visit Plan

5.3 Hosting the Inspection

1. Prepare dedicated inspection room with:
   • Working internet and printer access
   • Log of documents accessed (Annexure-4)
2. Ensure only pre-verified staff interact with inspectors.
3. Provide requested documents promptly with control tracking.
4. Maintain daily briefing logs (Annexure-5).

5.4 Responding to Observations

1. Review observations (Form 483, NAI, VAI, or EIR formats).
2. Draft Corrective and Preventive Action (CAPA) plan in response to findings (Annexure-6).
3. Submit response within agency-specified timelines (e.g., 15 days for FDA).
4. Track implementation of CAPA and close documentation formally.

5.5 Post-Inspection Activities

1. Hold debriefing meeting with staff and sponsor to discuss outcomes.
2. Archive all inspection-related documents securely in TMF/ISF.
3. Update site readiness plan based on lessons learned.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• CAPA: Corrective and Preventive Action
• CDSCO: Central Drugs Standard Control Organization
• FDA: Food and Drug Administration

7. Documents

1. Inspection Readiness Checklist – Annexure-1
2. Mock Audit Report – Annexure-2
3. Inspector Visit Plan – Annexure-3
4. Document Access Log – Annexure-4
5. Daily Briefing Log – Annexure-5
6. CAPA Response Template – Annexure-6

8. References

• ICH E6(R2) – Good Clinical Practice
• CDSCO Inspection Guidelines
• FDA Investigator Operations Manual
• EMA Clinical Trial Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Inspection Readiness Checklist

Area	Compliance Status	Remarks
ISF completeness	Compliant	All documents filed

Annexure-2: Mock Audit Report

Date	Auditor	Findings	Action Taken
10/04/2025	QA Head	Labeling delay	Retraining completed

Annexure-3: Inspector Visit Plan

Date	Agency	Contact Person	Coordinator Assigned
18/04/2025	CDSCO	Mr. R. Sharma	Rajesh Kumar

Annexure-4: Document Access Log

Date	Document Accessed	Requested By	Issued By	Returned
18/04/2025	CRF BE-121	Inspector	Sunita Reddy	Yes

Annexure-5: Daily Briefing Log

Date	Topics Discussed	Attendees	Key Actions
18/04/2025	Day 1 Findings	Site + QA	Prepare CAPA draft

Annexure-6: CAPA Response Template

Observation	Root Cause	Corrective Action	Preventive Action	Responsible
Late SAE reporting	Inadequate training	Immediate notification SOP revised	Annual refresher training	CRA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	Regulatory Compliance	QA Head
17/04/2025	2.0	Added inspection logistics, briefing, and tracking formats	Internal Review	QA Head