Standard Operating Procedure for Preparing for GCP Inspections and Audit Readiness in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/048/2025
Supersedes	SOP/BA-BE/048/2022
Page No.	Page 1 of 13
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the procedure for preparing Bioavailability/Bioequivalence (BA/BE) studies for Good Clinical Practice (GCP) inspections and audits by regulatory authorities and independent quality teams, ensuring continuous readiness and compliance with applicable guidelines.

2. Scope

This SOP applies to all BA/BE studies conducted or managed by the organization that are subject to inspection or audit by regulatory agencies such as US FDA, EMA, CDSCO, WHO, or internal quality assurance teams.

3. Responsibilities

• Quality Assurance (QA): Leads inspection planning, conducts mock audits, and supports documentation control.
• Clinical Project Manager: Coordinates site readiness, document availability, and staff preparedness.
• Principal Investigator (PI): Ensures site compliance and participation in inspection activities.

4. Accountability

The Head of Clinical Operations and Head of QA are jointly accountable for ensuring inspection preparedness across all studies and timely implementation of corrective actions post-inspection.

5. Procedure

5.1 Inspection Notification and Planning

1. Upon receipt of inspection notice, notify QA, Regulatory Affairs, and Clinical teams within 1 working day.
2. Assign a central Inspection Coordinator.
3. Develop a timeline and checklist using Annexure-1: GCP Inspection Readiness Plan.

5.2 Document Review and Compilation

1. Ensure the following are available and updated:
   • Trial Master File (TMF)
   • Investigator Site File (ISF)
   • Monitoring visit reports
   • Informed Consent Forms
   • Training records
   • Sample accountability logs
2. Use Annexure-2: Essential Document Checklist for tracking readiness.

5.3 Personnel Preparation

1. Identify team members likely to be interviewed and conduct pre-inspection briefing sessions.
2. Ensure team is familiar with:
   • Study protocol
   • Adverse event handling
   • Data entry and corrections
   • Deviation management

5.4 Facility Preparation

1. Prepare designated inspection room with:
   • Printer, scanner, secure Wi-Fi
   • Access to eTMF or TMF index
   • Confidentiality signage and controlled entry

5.5 Conduct During Inspection

1. Greet inspectors with inspection binder (Annexure-3: Inspection Binder Checklist).
2. Escort them at all times and maintain an Inspection Communication Log.
3. All requested documents must be logged and tracked for submission and return.

5.6 Post-Inspection Follow-Up

1. QA to draft response to observations (if any) within 7 working days.
2. Submit Corrective and Preventive Action (CAPA) using Annexure-4: Inspection CAPA Template.
3. Update Annexure-5: Audit Outcome Log with inspection status and lessons learned.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• GCP: Good Clinical Practice
• PI: Principal Investigator
• QA: Quality Assurance
• TMF: Trial Master File
• CAPA: Corrective and Preventive Action

7. Documents

1. GCP Inspection Readiness Plan – Annexure-1
2. Essential Document Checklist – Annexure-2
3. Inspection Binder Checklist – Annexure-3
4. Inspection CAPA Template – Annexure-4
5. Audit Outcome Log – Annexure-5

8. References

• ICH E6(R2) – Good Clinical Practice
• FDA Bioresearch Monitoring (BIMO) Program Guidelines
• EMA GCP Inspectors Working Group Documents
• WHO Operational Guidelines for Ethics Review

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: GCP Inspection Readiness Plan

Activity	Owner	Target Date	Status
Mock Audit	QA Team	10/04/2025	Completed

Annexure-2: Essential Document Checklist

Document	Version	Available (Y/N)	Remarks
Final Protocol	v1.2	Yes	Signed copy in TMF

Annexure-3: Inspection Binder Checklist

Section	Contents
Section 1	Intro Letter, Organization Chart
Section 2	Protocol, IB, ICF, EC Approvals

Annexure-4: Inspection CAPA Template

Observation	Root Cause	Corrective Action	Preventive Action	Owner
ICF Version mismatch	Outdated file used at site	Retrain site team	Document control SOP revised	Sunita Reddy

Annexure-5: Audit Outcome Log

Date	Agency	Outcome	Major Findings	Resolution Status
15/04/2025	CDSCO	Acceptable	1 CAPA issued	Closed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial release	First-time documentation	QA Head
17/04/2025	2.0	Annexures expanded, inspection room readiness added	Audit preparedness enhancement	QA Head