chambers, document the issues, and coordinate with the Stability Manager.

Stability Technicians: Monitor stability chambers, document deviations, and assist in the execution of contingency plans.

Quality Assurance (QA) Team: Review and approve deviation reports and corrective actions.

Procedure

1. Monitoring and Detection:
   • Continuously monitor stability
     

     Formulation Characterization and Stability of Protein Drugs

     chambers for temperature, humidity, and other critical storage conditions using automated systems and manual checks.
   • Set up alarm systems to notify relevant personnel immediately in case of any deviation from specified conditions.
   • Record all deviations in a logbook or electronic system, including date, time, and nature of the deviation.
2. Immediate Actions:
   • Notify the Stability Manager and Maintenance Technicians immediately upon detection of a chamber breakdown or condition deviation.
   • Stability Technicians should promptly assess the extent of the deviation and its potential impact on the stored samples.
   • Quarantine affected samples and move them to an alternative, validated storage environment if necessary and feasible.
   • Document the actions taken, including the time of detection, personnel involved, and the initial assessment.
3. Investigation and Impact Assessment:
   • Conduct a detailed investigation to identify the root cause of the breakdown or deviation.
   • Assess the impact on the stability study, considering the duration and extent of the deviation.
   • Evaluate whether the samples remain within acceptable stability limits or if additional testing is required to determine their integrity.
   • Document all findings from the investigation and impact assessment.
4. Corrective and Preventive Actions (CAPA):
   • Implement corrective actions to address the root cause of the chamber breakdown or condition deviation.
   • Develop preventive actions to avoid recurrence, such as enhancing monitoring systems, improving maintenance schedules, or retraining personnel.
   • Document the CAPA plan and obtain approval from the Stability Manager and QA Team.
   • Monitor the effectiveness of CAPA through follow-up checks and audits.
5. Resumption of Stability Study:
   • Once the stability chamber is repaired and validated, or a new chamber is designated, resume the stability study under the specified conditions.
   • Ensure that all affected samples are reconditioned according to the stability protocol before continuing the study.
   • Document the resumption of the study, including any adjustments to the study timeline or protocol.
6. Reporting and Documentation:
   • Prepare a comprehensive deviation report that includes:
     • Description of the breakdown or deviation and initial observations
     • Details of the immediate actions taken
     • Investigation findings and impact assessment
     • Root cause analysis and CAPA plan
     • Approval signatures from the Stability Manager and QA Team
   • Ensure that the final report is reviewed and approved by the Stability Manager and QA Team.
   • Store the deviation report in the stability study records and ensure it is accessible for regulatory review.

Abbreviations Used

• CAPA: Corrective and Preventive Actions
• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Stability Protocol
• Deviation Logs
• Maintenance Records
• Deviation Reports
• CAPA Records
• 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]