Packaging and Labeling of Stability Testing Samples

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for packaging stability samples. This ensures that the samples are protected from environmental factors and remain in a suitable condition for stability testing.

Scope

This SOP applies to all stability samples, including drug substances and drug products, that require packaging prior to storage in stability chambers for testing.

Responsibilities

• Stability Manager: Ensure proper packaging procedures are followed and that all materials meet regulatory requirements.
• Stability Technicians: Implement packaging procedures as specified and ensure proper labeling and documentation.
• Quality Assurance (QA) Team: Review and approve packaging procedures and ensure adherence to regulatory standards.

Procedure

1. Preparation for Packaging:
   • Ensure that the workspace is clean and free from contaminants.
   • Gather all necessary materials, including packaging containers, labels, and sealing equipment.
   • Verify that all packaging materials meet regulatory and internal quality standards.
2. Selection of Packaging Containers:
   • Select appropriate packaging containers based on the type and quantity of the
     

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     stability sample.
   • Use containers that are compatible with the sample and provide adequate protection from environmental factors.
3. Packaging of Samples:
   • Place stability samples into the selected packaging containers.
   • Ensure that samples are properly sealed to prevent contamination or degradation.
   • Use tamper-evident seals where applicable.
4. Labeling of Packages:
   • Label each package with the following information:
     • Sample identifier
     • Batch number
     • Storage conditions
     • Time points for testing
     • Any special handling instructions
   • Ensure that labels are legible and securely attached to the packages.
5. Documentation:
   • Record all relevant information in the stability protocol and associated logs.
   • Document the date of packaging, the personnel involved, and any observations during the packaging process.
6. Quality Control:
   • Conduct a final inspection of the packaged samples to ensure compliance with SOP and regulatory standards.
   • Address any discrepancies or issues identified during the inspection.
7. Storage of Packaged Samples:
   • Store the packaged samples in designated stability chambers under specified conditions.
   • Ensure proper organization within the storage units by study, batch, and time point.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Stability Protocol
• Packaging Records
• Labeling Records
• Storage Condition Monitoring Logs
• Audit Reports

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]