BA-BE Studies: SOP for Archival of Regulatory Correspondence – V 2.0

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BA-BE Studies: SOP for Archival of Regulatory Correspondence – V 2.0

Standard Operating Procedure for Archival of Regulatory Correspondence in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/025/2025
Supersedes SOP/BA-BE/025/2022
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 proper documentation, classification, indexing, and long-term archival of regulatory correspondence related to Bioavailability/Bioequivalence (BA/BE) studies to ensure traceability and compliance with applicable guidelines.

2. Scope

This SOP applies to all regulatory communications including emails, letters, submission receipts, query responses, approvals, and meeting notes exchanged with regulatory authorities (e.g., CDSCO, USFDA, EMA) for BA/BE studies managed by the organization.

3. Responsibilities

  • Regulatory Affairs: Responsible for maintaining and archiving all regulatory correspondence.
  • Clinical Project Manager: Provides study-specific updates and ensures timely forwarding of relevant communications.
  • Quality Assurance: Performs periodic checks to ensure completeness and accessibility of archives.
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4. Accountability

The Director – Regulatory Affairs is accountable for ensuring all correspondence is archived securely, accessible for inspection, and retained as per regulatory timelines.

5. Procedure

5.1 Classification of Regulatory Correspondence

  1. Types of correspondence to be archived:
    • Submission Acknowledgments
    • Query Letters and Responses
    • Approval Letters
    • Meeting Minutes
    • Email Correspondence with Authorities
    • Form 44 communications (India)
  2. Use Annexure-1: Regulatory Correspondence Index Log to categorize documents.

5.2 Documentation and Storage

  1. All communication must be saved in PDF format and named using:
    [StudyCode]_[Authority]_[DocType]_[Date].pdf
  2. Maintain a central Regulatory Archive Folder with access restricted to authorized personnel.
  3. Ensure each entry is documented in Annexure-2: Regulatory Archive Register.

5.3 Email Correspondence Archiving

  1. Convert important emails to PDF format.
  2. Attach any attachments (letters, responses) as supporting files in the archive folder.
  3. Document email threads that contain approvals, clarifications, or study-specific decisions.
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5.4 Version Control and Updates

  1. Track all responses and submissions with version control, indicating superseded and active versions in the index.
  2. Any updated documents must retain previous version(s) for traceability.

5.5 Retention Period and Disposal

  1. Retain all regulatory correspondence for at least 5 years after study completion or as required by local regulations.
  2. Prepare Annexure-3: Disposal Record prior to any destruction of outdated correspondence, with QA approval.

6. Abbreviations

  • BA: Bioavailability
  • BE: Bioequivalence
  • CDSCO: Central Drugs Standard Control Organization
  • EMA: European Medicines Agency
  • QA: Quality Assurance

7. Documents

  1. Regulatory Correspondence Index Log – Annexure-1
  2. Regulatory Archive Register – Annexure-2
  3. Disposal Record Form – Annexure-3

8. References

  • ICH E6(R2) – Good Clinical Practice
  • Schedule Y – Drugs and Cosmetics Rules
  • USFDA Guidance on Document Retention
  • EMA Clinical Trial Regulation (EU No. 536/2014)
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Regulatory Correspondence Index Log

Study Code Authority Type File Name Date
BE-034 CDSCO Query Response BE034_CDSCO_QueryResponse_160425.pdf 16/04/2025

Annexure-2: Regulatory Archive Register

Document Title Study Code Version Location Access Level
Approval Letter BE-034 V1.0 Reg_Folder/BE034/Approvals Restricted

Annexure-3: Disposal Record Form

Document Name Study Code Date Archived Date of Disposal Approved By
Initial Submission Email BE-030 12/02/2020 15/03/2025 QA Head

Revision History:

Revision Date Revision No. Details Reason Approved By
12/01/2022 1.0 Initial SOP New SOP Implementation QA Head
17/04/2025 2.0 Enhanced with digital archiving process and audit trails Regulatory Compliance QA Head
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