Procedure for Preparing Stability Study Protocols
| Department | Quality Control (QC)/Quality Assurance (QA)/Research & Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/106 |
| 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 define the process for preparing stability study protocols for ointments. This ensures that stability studies are conducted systematically, following regulatory guidelines and Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Research & Development (R&D) departments involved in designing, reviewing, and approving stability study protocols.
3. Responsibilities
- QC Analyst: Assists in protocol preparation and execution of stability tests.
- QC Supervisor: Ensures protocol adherence and regulatory compliance.
- QA Officer: Reviews and approves stability study protocols.
- R&D Scientist: Defines study parameters and evaluates data trends.
- QA Manager: Approves final protocols and ensures compliance with ICH guidelines.
4. Accountability
The QA and QC Managers are accountable for ensuring stability study protocols align with ICH Q1A(R2) guidelines.
5. Procedure
5.1 Components of a Stability Study Protocol
The stability study protocol must include the following details:
- Objective: Define the purpose of the stability study.
- Scope: Outline the product details, including formulation, batch size, and packaging.
- Study Design: Specify study conditions, testing parameters, and
acceptance criteria.
Storage Conditions: Define the environmental conditions based on ICH guidelines:
Sampling Intervals: Define time points for analysis (e.g., 0, 3, 6, 9, 12, 18, 24, and 36 months).
Testing Parameters: Include physical, chemical, and microbiological stability tests.
Acceptance Criteria: Define the limits for each parameter.
Documentation Requirements: Specify record-keeping and reporting obligations.
- 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
5.2 Protocol Preparation and Review
- Draft the stability study protocol using a standardized template.
- Ensure alignment with regulatory requirements and product specifications.
- Submit the draft protocol for internal review by QC and QA.
- Address any comments and finalize the protocol.
- Obtain approval from the QA Manager before implementation.
5.3 Implementation and Monitoring
- Ensure storage of stability samples under the defined conditions.
- Monitor and document sample conditions regularly.
- Conduct stability testing at defined intervals.
- Record all observations and results in the Stability Study Log.
5.4 Protocol Amendments
- Evaluate the need for any protocol modifications.
- Document changes and obtain necessary approvals.
- Ensure consistency across all stability studies.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- RH – Relative Humidity
7. Documents
- Stability Study Protocol Template (Annexure-1)
- Stability Study Approval Record (Annexure-2)
8. References
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- WHO GMP Guidelines for Pharmaceutical Stability Studies
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 Study Protocol Template
| Section | Details |
|---|---|
| Objective | Define the purpose of the stability study. |
| Scope | Include product name, batch number, formulation. |
| Study Design | Specify storage conditions and test parameters. |
| Sampling Intervals | 0, 3, 6, 9, 12, 18, 24, and 36 months. |
| Acceptance Criteria | Define the stability limits for all parameters. |
Annexure-2: Stability Study Approval Record
| Study ID | Product Name | Batch Number | Approved By | Approval Date |
|---|---|---|---|---|
| STB-001 | Ointment A | OINT-601 | QA Manager | 01/02/2025 |
| STB-002 | Ointment B | OINT-602 | QA Manager | 01/03/2025 |
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 |