Standard Operating Procedure for Review of Product Monograph and Prescribing Information in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/032/2025 |
| Supersedes | SOP/BA-BE/032/2022 |
| 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 reviewing and analyzing the product monograph and prescribing information of reference and test products used in Bioavailability/Bioequivalence (BA/BE) studies, in order to ensure clinical relevance, regulatory compliance, and protocol alignment.
2. Scope
This SOP applies to all BA/BE studies for which product-related documents such as the Summary of Product Characteristics (SmPC), Package Inserts (PI), or Drug Monographs are used to guide dose selection, safety review, and protocol development.
3. Responsibilities
- Medical Affairs: Leads the review of clinical data from monographs.
- Regulatory Affairs: Verifies the validity and regulatory acceptance of product labeling information.
- Clinical Project Team: Utilizes the reviewed information in protocol, ICF, and investigator training documents.
4. Accountability
The Head of Regulatory Affairs is accountable for ensuring that only the most current, approved, and regionally appropriate product monographs are used and filed for regulatory and EC submissions.
5. Procedure
5.1 Identification and Collection
- Obtain product monograph or SmPC from:
- Manufacturer’s website
- Health authority databases (e.g., USFDA, EMA, CDSCO)
- Drug compendia (e.g., Health Canada DB, BNF)
- Ensure documents are in English or accompanied by a certified translation.
5.2 Review Criteria
- Review for the following sections:
- Indications and usage
- Dosage and administration
- Contraindications and precautions
- Pharmacokinetics (absorption, distribution, metabolism, excretion)
- Drug interactions
- Special population guidance (renal/hepatic impairment)
- Adverse effects profile
- Compare data across regional documents if conducting global studies.
5.3 Documentation and Use
- Complete Annexure-1: Product Monograph Review Summary.
- Highlight data used for:
- Study design justification
- Dose rationale
- Inclusion/exclusion criteria
- Safety monitoring procedures
- File reviewed documents in Trial Master File and Investigator Site File.
5.4 Version Control and Updates
- Ensure the version used is the latest approved by relevant health authority.
- If updates occur during the study, re-review and assess for protocol amendment triggers.
6. Abbreviations
- SmPC: Summary of Product Characteristics
- PI: Prescribing Information
- CIB: Clinical Investigator’s Brochure
- EC: Ethics Committee
- TMF: Trial Master File
7. Documents
- Product Monograph Review Summary – Annexure-1
8. References
- ICH E6(R2) – Good Clinical Practice
- CDSCO Guidelines on Clinical Trials
- EMA and USFDA Labeling Guidance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Product Monograph Review Summary
| Product Name | Monograph Source | Date Reviewed | Reviewed By | Key Observations |
|---|---|---|---|---|
| XYZ 100 mg Tablet | USFDA Label | 15/04/2025 | Dr. Arvind Shah | Dose to be administered under fasting condition |
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 | Expanded review scope and added global referencing | Protocol standardization | QA Head |