Standard Operating Procedure for Review of Prescribing Information and Package Leaflets
| Department | Regulatory Affairs |
| SOP No. | RA/2026/747 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 15/04/2026 |
| Effective Date | 15/04/2026 |
| Review Date | 15/04/2028 |
Purpose
This Standard Operating Procedure (SOP) establishes the systematic process for the comprehensive review, verification, and control of prescribing information and package leaflets associated with pharmaceutical products. It ensures that all labeling documents comply with applicable regulatory requirements, internal quality standards, and are accurate and consistent prior to submission, approval, and distribution.
Scope
This SOP applies to all activities involved in the review of prescribing information and package leaflets for human pharmaceutical dosage forms within the Regulatory Affairs department. It covers initial review, amendments, updates due to safety information, labeling changes, and final approval for regulatory submissions. The SOP excludes artwork production, printing processes, and post-distribution inspections.
Responsibilities
- Regulatory Affairs Officers: Execute the detailed review and reconciliation of prescribing information and package leaflets.
- Medical Affairs/Pharmacovigilance Teams: Provide clinical and safety input for content accuracy.
- Quality Assurance: Oversee compliance to regulatory and internal standards, performing final approval.
- Document Control: Ensure correct version control and archiving of reviewed documents.
- Supervisors/Managers: Monitor and review the review process and escalate issues.
Accountability
The Head of Regulatory Affairs is accountable for the overall implementation, compliance monitoring, periodic review, management of deviations, and continuous effectiveness of this SOP.
Procedure
The review of prescribing information and package leaflets shall be conducted in a structured manner to guarantee regulatory compliance, accuracy, and clarity as follows:
1. Preparation and Prerequisites
- Obtain the latest draft of prescribing information and package leaflets requiring review.
- Gather reference documents including latest regulatory guidelines, previous approved labels, and company-specific templates.
- Ensure all source data such as clinical study reports, safety updates, and regulatory directives are accessible for cross verification.
2. Initial Document Review
- Review document formatting, completeness, and compliance with applicable regulatory templates and format guidance.
- Check for proper inclusion of critical safety information, indications, dosage instructions, contraindications, and warnings.
- Verify consistency between prescribing information and package leaflet content.
3. Scientific and Clinical Verification
- Coordinate with Medical Affairs or Pharmacovigilance to validate clinical statements and safety updates.
- Assess any recent changes in product labeling prompted by new clinical data or regulatory communications.
4. Compliance and Quality Checks
- Confirm adherence to local and international regulatory requirements, including font size, language clarity, and content layout.
- Ensure traceability of changes through documented version control and change logs.
- Perform a final quality check on grammar, spelling, and formatting consistency.
5. Review Approval Workflow
- Document all comments, queries, and corrections using the prescribed review forms.
- Circulate revised drafts for sequential review by relevant stakeholders including Regulatory Affairs, Medical, QA, and Legal if applicable.
- Obtain formal approvals documented on designated approval sheets prior to regulatory submission.
6. Documentation and Record Retention
- Archive all reviewed versions, approvals, correspondence, and related documents in accordance with company document control procedures.
- Maintain accessibility for audit, inspection, or future reference in secured electronic or physical repositories.
7. Handling Deviations and Updates
- Identify and document any deviations from this SOP or regulatory requirements discovered during review.
- Implement corrective actions and update the prescribing information/package leaflet accordingly.
- Schedule periodic reviews to incorporate new scientific data or regulatory updates.
This procedure ensures a robust control and review mechanism supporting compliance, patient safety, and product integrity throughout the labeling lifecycle.
Abbreviations
- QA: Quality Assurance
- RA: Regulatory Affairs
- PV: Pharmacovigilance
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
Documents
- Prescribing Information Review Checklist (Annexure-1)
- Package Leaflet Verification Form (Annexure-2)
- Labeling Change Approval Sheet (Annexure-3)
References
- ICH Guidelines on Labeling (ICH Q7, Q9)
- EU Directive 2001/83/EC on medicinal product labeling
- FDA Guidance for Industry: Labeling for Human Prescription Drugs
- Company Document Control and Quality Management System Policies
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Prescribing Information Review Checklist
Purpose: To systematically verify all critical elements in prescribing information to ensure compliance and accuracy before approval.
| Field | Details / Comments |
|---|---|
| Document Version | v1.2 |
| Review Date | 10/04/2026 |
| Reviewed By | Regulatory Affairs Officer |
| Completeness Check | All mandatory sections present |
| Safety Information Verified | Yes, cross-checked with PV |
| Consistency with Previous Version | Confirmed |
| Comments | Updated dosage for pediatrics |
| Signature | [Signature] |
Annexure-2: Package Leaflet Verification Form
Purpose: To document detailed verification of package leaflet contents ensuring regulatory compliance and readability.
| Field | Details / Comments |
|---|---|
| Package Leaflet ID | PL-2026-015 |
| Version | v3.0 |
| Verification Date | 12/04/2026 |
| Verified By | Regulatory Affairs Officer |
| Language Accuracy | Confirmed, no errors |
| Font & Format Compliance | Compliant with guidelines |
| Safety Warnings Included | Yes, per latest safety data |
| Comments | Adjusted layout for legibility |
| Signature | [Signature] |
Annexure-3: Labeling Change Approval Sheet
Purpose: To provide documented formal approval of labeling changes prior to submission or implementation.
| Field | Details / Comments |
|---|---|
| Change Request ID | CR-2026-042 |
| Description of Change | Update to pregnancy warnings in package leaflet |
| Date Submitted | 13/04/2026 |
| Reviewed By | Regulatory Affairs Manager |
| QA Approval | Approved |
| Approval Date | 14/04/2026 |
| Signature | [Signature] |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 15/04/2026 | 1.0 | Initial issue | New SOP creation |