Monitoring Stability Studies in Formulation Development
1) Purpose
The purpose of this SOP is to outline the procedure for monitoring stability studies during the formulation development process, ensuring that stability conditions are maintained and data integrity is preserved.
2) Scope
This SOP applies to all formulation development projects within the organization, covering the monitoring of stability studies for new formulations, changes, or renewals.
3) Responsibilities
The responsibilities for this SOP include:
Formulation Development Team: Implementing and overseeing stability study protocols, including monitoring and data collection.
Quality Control: Monitoring stability conditions and conducting periodic testing of stability samples.
Quality Assurance: Reviewing stability study protocols and monitoring activities to ensure compliance with regulatory standards.
Regulatory Affairs: Supporting stability study monitoring and providing data for regulatory submissions.
4) Procedure
4.1 Study Initiation and Conditions
- Initiate stability studies according to approved protocols, including setting up stability chambers or conditions as per study requirements.
- Ensure stability chambers or storage conditions are qualified and maintained within specified temperature, humidity, and light conditions.
- Label and organize stability samples for easy identification and retrieval during monitoring.
4.2 Sampling and Testing
- Conduct scheduled sampling of stability samples at predefined intervals according to the stability protocol.
- Perform testing on stability samples using validated analytical methods to assess product quality attributes.
- Document all sampling and testing activities, including sample handling and storage conditions.
4.3 Data Recording and Analysis
- Record stability data accurately and in real-time, ensuring completeness and integrity of data entries.
- Review stability data for trends, deviations, and out-of-specification (OOS) results.
- Analyze stability data to assess product stability over time and determine shelf-life recommendations.
4.4 Reporting and Documentation
- Prepare stability study reports summarizing monitoring activities, data trends, and conclusions.
- Include recommendations for storage conditions, product shelf-life, and any necessary adjustments to stability protocols.
- Review and approve stability study reports before submission to regulatory agencies and internal stakeholders.
5) Abbreviations, if any
SOP: Standard Operating Procedure
OOS: Out-of-Specification
6) Documents, if any
Stability Study Protocol
Stability Monitoring Records
Stability Study Reports
Change Control Documentation
7) Reference, if any
– ICH Q1A(R2): Stability Testing of New Drug Substances and Products
– FDA Guidance for Industry: Stability Testing of Drug Substances and Products
8) SOP Version
Version 1.0