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
- Upon receipt of inspection notice, notify QA, Regulatory Affairs, and Clinical teams within 1 working day.
- Assign a central Inspection Coordinator.
- Develop a timeline and checklist using Annexure-1: GCP Inspection Readiness Plan.
5.2 Document Review and Compilation
- 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
- Use Annexure-2: Essential Document Checklist for tracking readiness.
5.3 Personnel Preparation
- Identify team members likely to be interviewed and conduct pre-inspection briefing sessions.
- Ensure team is familiar with:
- Study protocol
- Adverse event handling
- Data entry and corrections
- Deviation management
5.4 Facility Preparation
- 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
- Greet inspectors with inspection binder (Annexure-3: Inspection Binder Checklist).
- Escort them at all times and maintain an Inspection Communication Log.
- All requested documents must be logged and tracked for submission and return.
5.6 Post-Inspection Follow-Up
- QA to draft response to observations (if any) within 7 working days.
- Submit Corrective and Preventive Action (CAPA) using Annexure-4: Inspection CAPA Template.
- 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
- GCP Inspection Readiness Plan – Annexure-1
- Essential Document Checklist – Annexure-2
- Inspection Binder Checklist – Annexure-3
- Inspection CAPA Template – Annexure-4
- 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 |