the cleanliness and condition of the chambers, reporting any issues to the Stability Manager.

Quality Assurance (QA) Team: Conduct periodic inspections and audits to ensure proper sanitation and housekeeping practices are followed.

Procedure

1. Cleaning Schedule:
   • Develop a cleaning schedule for climatic chambers, including
     

     “Unlock the Secrets of Drug Stability: Essential Guide for Pharmaceutical Scientists to Ensure Safe and Effective Medications”

     daily, weekly, and monthly tasks.
   • Ensure that the cleaning schedule is clearly posted and accessible to all relevant personnel.
2. Daily Cleaning:
   • Wipe down all accessible surfaces inside the climatic chambers with a lint-free cloth dampened with a suitable cleaning agent.
   • Check and clean the door seals and gaskets to ensure they are free of debris and functioning correctly.
   • Inspect and clean the air vents and filters, removing any dust or particulate buildup.
   • Record the completion of daily cleaning activities in the designated logbook.
3. Weekly Cleaning:
   • Perform a more thorough cleaning of the interior surfaces, including shelves and trays, using a suitable disinfectant.
   • Inspect the chamber for any signs of mold, mildew, or other contaminants and address immediately if found.
   • Check the condition of temperature and humidity sensors, cleaning them carefully to avoid damage.
   • Document the completion of weekly cleaning activities in the cleaning logbook.
4. Monthly Cleaning:
   • Conduct a deep clean of the climatic chamber, including the removal and cleaning of all removable parts.
   • Sanitize the interior with an appropriate disinfectant and allow it to dry completely before reassembling.
   • Inspect and clean the external surfaces and surrounding area to ensure a contamination-free environment.
   • Complete the monthly cleaning checklist and record all activities in the logbook.
5. Inspection and Maintenance:
   • Regularly inspect the climatic chambers for any signs of wear, damage, or malfunction.
   • Schedule and perform preventive maintenance activities as per the manufacturer’s guidelines.
   • Address any identified issues promptly to avoid compromising the stability studies.
   • Maintain detailed records of all inspections and maintenance activities.
6. Handling Spills and Contamination:
   • Immediately clean any spills inside the climatic chambers using appropriate cleaning agents and techniques.
   • Document the spill incident, including the nature of the spill, cleaning actions taken, and any potential impact on stability studies.
   • Report significant spills or contamination events to the Stability Manager and QA Team.
7. Record Keeping:
   • Maintain cleaning logs and checklists for daily, weekly, and monthly cleaning activities.
   • Ensure records are complete, accurate, and signed by the personnel performing the tasks.
   • Archive records according to the facility’s document retention policy and regulatory requirements.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Cleaning Schedule
• Cleaning Logbook
• Maintenance Records
• Inspection Checklists
• Spill Incident 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]