management processes for container-liner-closure systems.

Procedure

1. Selection of Container-Liner-Closure Systems:
   • Identify the type of drug product (e.g., tablet, capsule, liquid) and the appropriate container-liner-closure system.
   • Ensure that the selected systems comply with regulatory guidelines and are suitable for the intended storage conditions.
   • Consider factors such as material compatibility, barrier
     

     “The Assurance of Safe and Effective Medications: Cutting-edge Methods for Pharmaceutical Stability Testing Unveiled”

     properties, and protection against light and moisture.
   • Document the rationale for the selection of each container-liner-closure system.
2. Qualification of Container-Liner-Closure Systems:
   • Perform qualification studies to ensure the container-liner-closure system maintains product stability and integrity.
   • Conduct tests for container integrity, extractables/leachables, and compatibility with the drug product.
   • Document the results of qualification studies and approve the container-liner-closure systems for use in stability studies.
3. Packaging Procedure:
   • Ensure the cleanliness and suitability of containers, liners, and closures before use.
   • Fill containers with the drug product as per standard filling procedures, ensuring accurate and consistent fill volumes.
   • Apply liners and closures securely to prevent contamination and ensure seal integrity.
   • Label the containers with batch information, storage conditions, and sampling time points.
4. Storage and Handling:
   • Store the packaged stability samples under specified conditions (e.g., temperature, humidity) in stability chambers.
   • Ensure proper organization within the storage units by study, batch, and time point.
   • Handle containers carefully to avoid physical damage or compromise of the container-liner-closure system.
5. Documentation:
   • Document all aspects of the container-liner-closure system selection, qualification, and packaging processes.
   • Maintain records of qualification studies, including test methods, results, and approvals.
   • Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
6. Handling Deviations:
   • Investigate any deviations from the specified procedures or unexpected results related to container-liner-closure systems.
   • Document the deviation, including the date, time, personnel involved, and potential impact on the study.
   • Implement corrective actions to address the root cause and prevent recurrence.
   • Record corrective actions taken and review effectiveness.
7. Quality Control:
   • Perform a final review of the container-liner-closure system data to ensure accuracy and completeness.
   • QA Team to conduct periodic audits of container-liner-closure system records for compliance.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Container-Liner-Closure System Qualification Reports
• Packaging Records
• Stability Protocol
• Audit Reports
• Maintenance Records

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]