SOP Guide for Pharma

BA-BE Studies: SOP for Handling Inquiries from Regulatory Agencies – V 2.0

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BA-BE Studies: SOP for Handling Inquiries from Regulatory Agencies – V 2.0

Standard Operating Procedure for Handling Inquiries from Regulatory Agencies in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/050/2025
Supersedes SOP/BA-BE/050/2022
Page No. Page 1 of 11
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To establish a standardized and compliant process for receiving, evaluating, and responding to inquiries, clarification requests, and deficiency letters from regulatory agencies in relation to Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP applies to all communications and queries received from regulatory agencies including US FDA, EMA, CDSCO, WHO PQ, Health Canada, TGA, and other global health authorities concerning BA/BE study submissions or inspections.

3. Responsibilities

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4. Accountability

The Head of Regulatory Affairs is accountable for ensuring that all regulatory communications are addressed accurately, within the stipulated timelines, and are documented appropriately.

5. Procedure

5.1 Receipt and Acknowledgment of Inquiry

  1. All incoming communications from regulatory agencies must be acknowledged within 2 business days.
  2. Log the inquiry in Annexure-1: Regulatory Inquiry Log, including date received, agency, subject, and responsible owner.

5.2 Internal Evaluation and Assignment

  1. Regulatory Affairs to initiate a review meeting with relevant stakeholders within 3 working days of receipt.
  2. Classify the query as:
    • Administrative
    • Technical/Clinical
    • CMC (Chemistry, Manufacturing and Controls)
    • Safety-related
  3. Assign responsibilities to SMEs and define timelines using Annexure-2: Query Assignment Sheet.

5.3 Drafting the Response

  1. SMEs prepare the initial response draft with relevant data, justifications, and references.
  2. Regulatory Affairs reviews and consolidates responses into a unified document as per agency format (e.g., eCTD, PDF).

5.4 Quality Review and Approval

  1. Submit the compiled response for QA review using Annexure-3: Response Review Checklist.
  2. Correct any identified gaps or inconsistencies prior to final approval.
  3. Obtain formal approval and signatures using Annexure-4: Regulatory Submission Approval Form.
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5.5 Submission and Documentation

  1. Submit the final response via official regulatory portal (e.g., ESG, XEVMPD, SUGAM).
  2. Maintain a copy in the Trial Master File (TMF) or Regulatory Archive.
  3. Update Annexure-1 with submission date and closure remarks.

5.6 Follow-Up and Tracking

  1. Monitor agency portals/emails for confirmation of receipt or further communication.
  2. Log any follow-up queries in Annexure-5: Response Tracking and Resolution Log.

6. Abbreviations

7. Documents

  1. Regulatory Inquiry Log – Annexure-1
  2. Query Assignment Sheet – Annexure-2
  3. Response Review Checklist – Annexure-3
  4. Regulatory Submission Approval Form – Annexure-4
  5. Response Tracking and Resolution Log – Annexure-5

8. References

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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 Inquiry Log

Date Received Agency Subject Owner Status
12/04/2025 US FDA Request for dissolution data Sunita Reddy Closed

Annexure-2: Query Assignment Sheet

Query No. Description Assigned To Due Date Status
Q-001 Provide comparative PK justification Rajesh Kumar 15/04/2025 Submitted

Annexure-3: Response Review Checklist

Check Point Status Reviewer Comments
Scientific Justification Adequate Yes Well-documented

Annexure-4: Regulatory Submission Approval Form

Submission Title Date Approved By Designation
ANDA IR-2025-Q2 16/04/2025 Dr. Arvind Shah Head – Regulatory Affairs

Annexure-5: Response Tracking and Resolution Log

Agency Initial Response Date Follow-up Date Final Status Remarks
EMA 10/03/2025 22/03/2025 Accepted Query resolved with no further request

Revision History:

Revision Date Revision No. Details Reason Approved By
15/01/2022 1.0 Initial version First formal documentation QA Head
17/04/2025 2.0 Incorporated annexures and multi-agency support Enhancement for global compliance QA Head
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