Sample Storage Setup for Stability Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for configuring the storage environment for stability study samples to ensure consistency, compliance, and integrity of the samples.

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 configuration and ensure it meets regulatory guidelines and company standards.
• Stability Technicians: Implement the storage configuration 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

1. Review Stability Protocol:
   • Ensure the stability protocol specifies the storage conditions (e.g., temperature, humidity) for each sample type.
2. Prepare Storage Environment:
   • 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.
3. Organize Samples:
   • Assign each sample a specific location within the
     

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     storage unit.
   • Use labeled shelves, racks, or compartments to organize samples by study, batch, and time point.
4. Monitor Storage Conditions:
   • 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.
5. Document Storage Configuration:
   • 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.
6. Perform Regular Audits:
   • Conduct regular audits of the storage environment to ensure ongoing compliance with specified conditions.
   • Document audit findings and take corrective actions if necessary.
7. Review and Approval:
   • Submit the storage configuration 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.
8. Communication:
   • Communicate the finalized storage configuration 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]