Standard Operating Procedure for Storage Area Qualification and Mapping

Purpose

The purpose of this SOP is to establish procedures for the qualification and mapping of storage areas within the pharmaceutical distribution facility to ensure compliance with regulatory requirements and maintain appropriate storage conditions for pharmaceutical products.

Scope

This SOP applies to all personnel involved in the qualification and mapping of storage areas, including facility management staff, quality assurance professionals, and validation engineers, within the distribution facility.

Responsibilities

• The Facility Manager is responsible for overseeing storage area qualification and mapping activities, ensuring compliance with regulatory requirements and company standards.
• The Quality Assurance Manager is responsible for reviewing and approving storage area qualification protocols, monitoring the execution of qualification activities, and verifying compliance with established procedures.
• All personnel involved in storage area qualification and mapping are responsible for following procedures outlined in this SOP and adhering to validation protocols to ensure accuracy and completeness of qualification activities.

Procedure

1. Storage Area Qualification Plan:
   • Develop a storage area qualification plan outlining the objectives, scope, and methodology for qualifying storage areas, including temperature-controlled storage areas, ambient storage areas, and quarantine areas.
   • Identify critical parameters to be monitored during qualification, such as temperature, humidity, airflow, and particulate levels, based on regulatory requirements and product storage specifications.
2. Temperature Mapping:
   • Conduct temperature mapping studies to assess temperature distribution and variability within storage areas under different operating conditions, including empty and loaded conditions, seasonal variations, and worst-case scenarios.
   • Install temperature mapping sensors at predetermined locations throughout the storage area, ensuring adequate coverage of critical storage areas and monitoring points.
3. Data Collection and Analysis:
   • Collect temperature and other relevant data during mapping studies using calibrated monitoring equipment and data loggers, recording data at specified intervals to capture temperature fluctuations and trends over time.
   • Analyze mapping data to evaluate temperature uniformity, identify hot spots or cold spots within the storage area, and determine the impact of environmental factors on storage conditions.
4. Qualification Report:
   • Prepare a qualification report summarizing the results of storage area qualification activities, including temperature mapping studies, data analysis, and conclusions regarding the suitability of storage areas for pharmaceutical storage.
   • Document any deviations or non-conformities identified during qualification activities, along with proposed corrective actions and follow-up measures to address deficiencies and ensure compliance with regulatory requirements.
5. Approval and Monitoring:
   • Obtain approval from the Quality Assurance Manager or designated personnel for the qualification report, ensuring that all findings, conclusions, and recommendations are accurately documented and supported by data.
   • Monitor storage area conditions regularly following qualification activities to verify continued compliance with established specifications and to identify any changes or deviations requiring corrective action.

Abbreviations

• SOP – Standard Operating Procedure

Documents

Reference documents related to storage area qualification and mapping may include:

• Storage area qualification plan
• Temperature mapping protocols
• Data collection and analysis records
• Qualification reports
• Regulatory guidelines on storage area qualification

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0