Standard Operating Procedure for Storage Conditions of Granules

1) Purpose

The purpose of this SOP is to define the standard storage conditions for granules in the pharmaceutical industry to maintain their stability and quality throughout their shelf-life.

2) Scope

This SOP applies to all personnel involved in the storage of granules within the pharmaceutical manufacturing facility.

3) Responsibilities

Warehouse Personnel: Responsible for implementing and monitoring storage conditions.
Quality Assurance: Responsible for ensuring compliance with storage requirements.
Production Managers: Responsible for coordinating storage activities.

4) Procedure

1. Storage Area Identification:
   1. Designate specific areas within the warehouse for granule storage.
   2. Ensure areas are clean, dry, and free from potential contaminants.
2. Temperature and Humidity Control:
   1. Set and monitor storage temperatures as per product specifications.
   2. Maintain humidity levels within acceptable limits to prevent degradation.
3. Light Protection:
   1. Store granules away from direct sunlight and artificial light sources that may degrade sensitive compounds.
   2. Use light-resistant containers or coverings when necessary.
4. Storage Conditions Monitoring:
   1. Regularly monitor and record storage temperatures and humidity levels.
   2. Document any deviations from specified conditions and take corrective actions promptly.
5. Security and Access Control:
   1. Implement security measures to prevent unauthorized access to stored granules.
   2. Ensure only authorized personnel have access to the storage areas.
6. Documentation:
   1. Maintain accurate records of storage conditions, including temperature logs and humidity records.
   2. Review and archive records as per document