Standard Operating Procedure for Preparing Product-Specific Guidance Review Summary in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/015/2025
Supersedes	SOP/BA-BE/015/2022
Page No.	Page 1 of 12
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a procedure for reviewing, interpreting, and summarizing Product-Specific Guidances (PSGs) issued by regulatory agencies such as the USFDA, EMA, and others, to guide the design and regulatory planning of Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP applies to Regulatory Affairs, Clinical, and Bioanalytical departments involved in the planning, protocol development, and execution of BE studies intended for submission in regulated markets.

3. Responsibilities

• Regulatory Affairs: Downloads, reviews, and circulates current product-specific guidance from relevant authorities.
• Clinical Pharmacologist: Assesses guidance recommendations and aligns study design accordingly.
• Bioanalytical Lead: Verifies sampling points, analyte specifications, and PK parameters listed.
• Medical Writer: Documents the review in the study protocol and maintains the summary in the eTMF.

4. Accountability

The Director of Regulatory Affairs is accountable for ensuring all BA/BE studies are supported by a current and accurate product-specific guidance review before protocol finalization.

5. Procedure

5.1 Identification and Retrieval of PSG

1. Visit official regulatory websites:
   • USFDA PSG Database
   • EMA Guideline Portal
2. Search by active ingredient name or RLD/RMP brand name.
3. Download the most recent version of the PSG.
4. Log details in Annexure-1: PSG Retrieval Record.

5.2 Review and Interpretation

1. Review the following key elements from the PSG:
   • Recommended study design (fasted/fed/crossover/parallel)
   • Analytical method and sampling requirements
   • Analyte(s) to be measured
   • PK parameters (AUC, Cmax, Tmax, etc.)
   • Waiver criteria (if applicable)
2. Cross-verify whether multiple PSGs exist for different strengths or dosage forms.
3. Summarize findings in Annexure-2: PSG Review Summary Template.

5.3 Internal Discussion and Study Alignment

1. Conduct cross-functional meetings with:
   • Clinical
   • Regulatory
   • Bioanalytical
2. Document consensus on study design and deviations from PSG (if any).
3. Update protocol rationale accordingly.

5.4 Filing and Archival

1. Save the original PSG and completed review summary in the eTMF.
2. Ensure PSG Review Summary is signed and dated by Regulatory Affairs.
3. Update PSG review tracker (Annexure-3).

6. Abbreviations

• PSG: Product-Specific Guidance
• BE: Bioequivalence
• PK: Pharmacokinetic
• RLD: Reference Listed Drug
• RMP: Reference Medicinal Product
• eTMF: Electronic Trial Master File

7. Documents

1. PSG Retrieval Record – Annexure-1
2. PSG Review Summary Template – Annexure-2
3. PSG Review Tracker – Annexure-3

8. References

• USFDA Product-Specific Guidance Portal
• EMA Guideline on the Investigation of Bioequivalence
• WHO Prequalification BE Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PSG Retrieval Record

Date	Product Name	Agency	Version	Retrieved By
10/04/2025	ABC Tablet 50 mg	USFDA	Feb 2024	Rajesh Kumar

Annexure-2: PSG Review Summary Template

Study Design	Fasted, 2×2 crossover
Analyte	ABC active moiety
PK Parameters	AUC0-t, AUC0-inf, Cmax
Sampling Points	Pre-dose, 0.5, 1, 2, 3… 72 hrs
Regulatory Remarks	No waiver recommended for any strength

Annexure-3: PSG Review Tracker

Product	PSG Date	Review Date	Status	Filed In
ABC 50 mg	Feb 2024	10/04/2025	Reviewed	eTMF/RA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial SOP	New Process Implementation	QA Head
17/04/2025	2.0	Added EMA review and annexure templates	Global Alignment	QA Head