Procedure for Ensuring Compliance with Stability Guidelines
| Department | Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs |
|---|---|
| SOP No. | SOP/Ointment/109 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for ensuring compliance with stability study guidelines, including ICH Q1A(R2), WHO GMP, and local regulatory requirements. This ensures the reliability of stability data and regulatory adherence.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs departments responsible for planning, executing, and monitoring stability studies.
3. Responsibilities
- QA Manager: Ensures compliance with stability testing guidelines and oversees study protocols.
- QC Analyst: Conducts stability testing as per approved protocols.
- Regulatory Affairs Officer: Reviews stability data for submission to regulatory agencies.
- QC Supervisor: Ensures adherence to predefined study conditions and protocol compliance.
- QA Officer: Verifies accuracy, consistency, and completeness of stability records.
4. Accountability
The QA and Regulatory Affairs Managers are accountable for ensuring compliance with ICH, WHO, and local regulatory guidelines for stability testing.
5. Procedure
5.1 Regulatory Compliance and Guidelines
- Ensure all stability studies comply with ICH Q1A(R2) and WHO stability testing guidelines.
- Confirm adherence to local regulatory agency requirements (e.g., US FDA, EMA, CDSCO).
- Review
stability study protocols to align with regulatory expectations.
5.2 Stability Study Design and Execution
- Design stability studies based on product formulation and packaging type.
- Define testing conditions as per regulatory standards:
- Long-term stability: 25°C ± 2°C / 60% RH ± 5% RH
- Intermediate stability: 30°C ± 2°C / 65% RH ± 5% RH
- Accelerated stability: 40°C ± 2°C / 75% RH ± 5% RH
- Ensure appropriate sample storage and periodic testing as per protocol.
5.3 Data Documentation and Integrity
- Maintain stability data in compliance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) principles.
- Ensure real-time documentation of all observations and deviations.
- Retain raw data and reports for regulatory audits and inspections.
5.4 Handling Deviations and Out-of-Specification (OOS) Results
- Investigate any deviations from predefined stability criteria.
- Document OOS results in the Stability Deviation Log.
- Perform root cause analysis and implement corrective and preventive actions (CAPA).
5.5 Periodic Review and Compliance Monitoring
- Conduct periodic stability study audits to verify regulatory adherence.
- Review and update stability protocols based on new guidelines or regulatory changes.
- Ensure stability reports are submitted to regulatory authorities in a timely manner.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- RH – Relative Humidity
- OOS – Out-of-Specification
- CAPA – Corrective and Preventive Action
- ALCOA+ – Attributable, Legible, Contemporaneous, Original, Accurate
7. Documents
- Stability Compliance Checklist (Annexure-1)
- Regulatory Compliance Report (Annexure-2)
8. References
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- WHO GMP Guidelines for Pharmaceutical Stability Studies
- US FDA and EMA Stability Testing Requirements
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Stability Compliance Checklist
| Compliance Area | Requirement | Status | Reviewed By |
|---|---|---|---|
| ICH Q1A(R2) Guidelines | Stability conditions followed | Compliant | QA Officer |
| WHO GMP Compliance | Study aligns with GMP | Compliant | QA Officer |
Annexure-2: Regulatory Compliance Report
| Batch Number | Testing Condition | Regulatory Requirement | Compliance Status | Reviewed By |
|---|---|---|---|---|
| OINT-901 | Long-Term Stability | ICH Q1A(R2) | Compliant | QA Manager |
| OINT-902 | Accelerated Stability | WHO GMP | Compliant | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |