SOP Guide for Pharma

BA-BE Studies: SOP for Reviewing Reference Product Literature – V 2.0

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BA-BE Studies: SOP for Reviewing Reference Product Literature – V 2.0

Standard Operating Procedure for Reviewing Reference Product Literature in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/002/2025
Supersedes SOP/BA-BE/002/2022
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 identifying, retrieving, and critically reviewing the reference product literature for the purpose of designing scientifically sound and regulatory-compliant bioavailability/bioequivalence (BA/BE) studies.

2. Scope

This SOP is applicable to the regulatory affairs, medical writing, and clinical research teams involved in the planning and design of BA/BE studies for generic and reformulated drug products intended for submission to global regulatory authorities.

3. Responsibilities

  • Regulatory Affairs Team: Responsible for sourcing reference product information from regulatory databases.
  • Medical Writer: Reviews and summarizes SmPC, FDA labels, and prescribing information for protocol development.
  • Clinical Pharmacologist: Assesses pharmacokinetics, safety, and dosing regimen details from the literature.
  • Project Manager: Ensures timely collection and distribution of reviewed documents to relevant stakeholders.
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4. Accountability

The Regulatory Affairs Head is accountable for ensuring that the reference product literature is up-to-date, relevant, and appropriately documented in the BA/BE study file.

5. Procedure

5.1 Identification of Reference Product

  1. Confirm the regulatory target market for the submission (e.g., US, EU, India).
  2. Identify the corresponding reference listed drug (RLD) or reference medicinal product (RMP).
  3. Verify dosage form, strength, and therapeutic indication from official databases:
    • USFDA Orange Book
    • EMA Community Register
    • CDSCO List of Approved Products

5.2 Collection of Regulatory Product Literature

  1. Download relevant documents from regulatory websites:
    • USFDA: Labeling Information, Product Insert
    • EMA: SmPC, Assessment Reports
    • CDSCO: Package Inserts (if available)
  2. Ensure that documents are current versions and record the download date.
  3. Store all documents in the designated “Reference Product Literature” folder in the eTMF.
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5.3 Data Extraction and Review

  1. Extract the following details:
    • Dosage regimen
    • Route of administration
    • Indications and contraindications
    • Pharmacokinetics (Cmax, Tmax, AUC, t1/2)
    • Food effect recommendations
  2. Document extracted data using Annexure-2: Literature Review Summary Template.

5.4 Internal Review and Compilation

  1. Submit the draft summary to the Clinical Research and Medical Writing teams.
  2. Incorporate feedback into the final document.
  3. Attach the summary to the protocol development package and archive in eTMF.

5.5 Literature Update Procedure

  1. Set review frequency for long-term projects (minimum once per year).
  2. Assign responsibility for periodic verification of label changes or updated SmPCs.
  3. Update literature summary with change logs if applicable.

6. Abbreviations

  • BA: Bioavailability
  • BE: Bioequivalence
  • SmPC: Summary of Product Characteristics
  • RLD: Reference Listed Drug
  • RMP: Reference Medicinal Product
  • eTMF: Electronic Trial Master File
  • CDSCO: Central Drugs Standard Control Organization

7. Documents

  1. Reference Literature Checklist – Annexure-1
  2. Literature Review Summary Template – Annexure-2
  3. Change Log for Updated Literature – Annexure-3
See also  BA-BE Studies: SOP for Crossover Period Washout Management - V 2.0

8. References

  • USFDA Orange Book Database
  • EMA Community Register
  • ICH M4: Common Technical Document for Registration

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Reference Literature Checklist

Document Source Version Date Verified By
FDA Label www.fda.gov 15/03/2025 Rajesh Kumar
EMA SmPC www.ema.europa.eu 18/03/2025 Sunita Reddy

Annexure-2: Literature Review Summary Template

Parameter Details
Indication Hypertension
Dosage 50 mg once daily
Cmax 650 ng/mL
Tmax 1.5 hours
Food Effect Present

Annexure-3: Change Log for Updated Literature

Date Change Description Reviewed By
05/04/2025 Updated SmPC with new adverse events section Neha Patil

Revision History:

Revision Date Revision No. Details Reason Approved By
12/01/2022 1.0 Initial SOP Creation New Requirement QA Head
17/04/2025 2.0 Added change log and updated templates Annual Review QA Head
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