the certification 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.
   • Document
     

     “Shelf Life Code: Prolonging the Potency of Injectable Medications with Extended Stability Measures”

     the rationale for the selection of each container-liner-closure system.
2. Qualification Studies:
   • 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 in a qualification report.
3. Certification of Container-Liner-Closure Systems:
   • Based on qualification results, certify the container-liner-closure system for use in stability studies.
   • Prepare a certification document that includes:
     • System description and specifications
     • Qualification study results
     • Compliance with regulatory guidelines
     • Approval signatures from the Stability Manager and QA Team
   • Maintain certification documents in the stability study records.
4. Documentation:
   • Document all aspects of the selection, qualification, and certification 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.
5. 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.
6. 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
• Certification Documents
• Stability Protocol
• 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]