Controlled Storage of Stability Study Samples Before Analysis
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for storing stability study samples under controlled conditions prior to analysis to ensure sample integrity and compliance with regulatory requirements.
Scope
This SOP applies to all stability study samples of drug substances and drug products within the pharmaceutical company’s facilities.
Responsibilities
- Stability Manager: Approve the storage procedures and ensure they meet regulatory guidelines and company standards.
- Stability Technicians: Implement the storage procedures as specified in this SOP and the stability protocol.
- Quality Assurance (QA) Team: Review and approve storage conditions and ensure compliance with documentation standards.
Procedure
- Review Stability
Protocol:
Prepare Storage Environment:
Organize Samples:
Monitor Storage Conditions:
Document Storage Details:
Perform Regular Audits:
Sample Handling Prior to Analysis:
Review and Approval:
Communication:
- Ensure the stability protocol specifies the controlled storage conditions (e.g., temperature, humidity) for each sample type prior to analysis.
- Set up storage chambers or units according to specified conditions (e.g., 25°C/60% RH, 30°C/65% RH, 40°C/75% RH).
- Calibrate and validate storage units to ensure they maintain the required conditions consistently.
- Assign each sample a specific location within the storage unit.
- Use labeled shelves, racks, or compartments to organize samples by study, batch, and time point.
- Install monitoring devices (e.g., temperature and humidity sensors) in each storage unit.
- Set up alarms and alerts for any deviations from the specified conditions.
- Regularly review monitoring data to ensure compliance with the stability protocol.
- Record the storage conditions and configuration details in the stability protocol and associated logs.
- Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
- Conduct regular audits of the storage environment to ensure ongoing compliance with specified conditions.
- Document audit findings and take corrective actions if necessary.
- Retrieve samples from storage shortly before the scheduled analysis time to maintain their integrity.
- Ensure minimal handling and exposure to uncontrolled conditions during transfer to the analysis area.
- Submit the storage procedures and monitoring plan to the Stability Manager and QA Team for review and approval.
- Make any necessary adjustments based on feedback and finalize the storage setup.
- Communicate the finalized storage procedures and monitoring plan to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.
Abbreviations Used
- QA: Quality Assurance
- RH: Relative Humidity
- SOP: Standard Operating Procedure
Documents
- Stability Protocol
- Storage Unit Calibration and Validation Records
- Storage Condition Monitoring Logs
- Audit Reports
- Regulatory Guidelines
References
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
SOP Version
Version 1.0 – Effective Date: [Insert Date]