Standard Operating Procedure for Establishing Quality Agreements with CROs in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/040/2025 |
| Supersedes | SOP/BA-BE/040/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for establishing formal Quality Agreements with Contract Research Organizations (CROs) involved in Bioavailability/Bioequivalence (BA/BE) studies to ensure mutual understanding of responsibilities, quality standards, and regulatory compliance.
2. Scope
This SOP applies to all CROs contracted for clinical operations, bioanalytical services, data management, pharmacovigilance, and other critical services in BA/BE studies sponsored or managed by the organization.
3. Responsibilities
- Quality Assurance (QA): Leads the drafting, review, and approval process of the Quality Agreement.
- Clinical Project Manager: Coordinates functional input and ensures agreement execution prior to study start.
- Legal and Contracts Department: Reviews legal language and ensures alignment with Master Service Agreement (MSA).
- CRO Representative: Reviews and signs agreement acknowledging their obligations.
4. Accountability
The Head of Quality is accountable for ensuring that no work is initiated by the CRO unless a fully executed Quality Agreement is in place, filed, and accessible to relevant stakeholders.
5. Procedure
5.1 Initiating the Quality Agreement
- Trigger for Quality Agreement initiation includes:
- Selection of a CRO for a BA/BE study
- Amendment or renewal of existing service contracts
- Use Annexure-1: Quality Agreement Template as the starting document.
5.2 Content of the Agreement
- The agreement shall include but not be limited to:
- Scope of services
- Compliance with ICH E6(R2), Schedule Y, GLP, and GCP
- Roles and responsibilities of both sponsor and CRO
- Data ownership and integrity
- Deviation and CAPA management
- Audit and inspection readiness
- Document retention and confidentiality
5.3 Review and Finalization
- Circulate the draft internally to relevant departments for comments using Annexure-2: Quality Agreement Review Log.
- Share the updated draft with CRO for mutual review and alignment.
- Legal department validates language prior to execution.
5.4 Execution and Archival
- Both parties sign the final document; each retains a signed copy.
- File executed agreement in Trial Master File (TMF) and QA Agreement Repository.
5.5 Monitoring and Amendment
- Review agreement validity annually or at the time of major protocol or service change.
- Any change in scope must be captured through an amended agreement with updated signatures.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
7. Documents
- Quality Agreement Template – Annexure-1
- Quality Agreement Review Log – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- EMA Reflection Paper on CRO Oversight
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Quality Agreement Template
| Section | Description |
|---|---|
| Scope | Defines services covered under the agreement |
| Responsibilities | Split of roles between sponsor and CRO |
| Quality Oversight | Describes monitoring, audit, and CAPA responsibilities |
Annexure-2: Quality Agreement Review Log
| Reviewer | Department | Date | Comments | Incorporated (Yes/No) |
|---|---|---|---|---|
| Rajesh Kumar | Regulatory | 14/04/2025 | Added reference to Schedule Y in clause 3 | Yes |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial SOP | New document | QA Head |
| 17/04/2025 | 2.0 | Annexures added, CRO roles clarified | Audit preparedness | QA Head |