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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:

Ensure the stability protocol specifies the controlled storage conditions (e.g., temperature, humidity) for each sample type prior to analysis.

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
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storage units to ensure they maintain the required conditions consistently.

Organize Samples:

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.

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.

Document Storage Details:

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.

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.

Sample Handling Prior to Analysis:

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.

Review and Approval:

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.

Communication:

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]