Standard Operating Procedure for Storage Conditions of Gels
1) Purpose
The purpose of this SOP is to define procedures for the proper storage of gels in the pharmaceutical industry to maintain their stability, integrity, and quality.
2) Scope
This SOP applies to all personnel responsible for storing gels within the pharmaceutical production facility.
3) Responsibilities
Warehouse Supervisor: Oversee storage procedures as per this SOP.
Production Operators: Ensure gels are stored correctly after manufacturing.
Quality Assurance (QA) Personnel: Verify compliance with storage conditions.
4) Procedure
4.1 Storage Area
4.1.1 Designate specific storage areas for gels based on temperature and humidity requirements.
4.1.2 Ensure storage areas are clean, well-organized, and suitable for pharmaceutical products.
4.2 Temperature and Humidity Control
4.2.1 Monitor and control temperature and humidity within specified ranges using calibrated monitoring devices.
4.2.2 Implement alarms and backup systems to alert personnel of deviations from set conditions.
4.3 Light Protection
4.3.1 Store gels in light-resistant containers or in areas protected from direct light exposure.
4.3.2 Avoid prolonged exposure to fluorescent or UV light sources that may degrade product quality.
4.4 Shelf-Life Monitoring
4.4.1 Label each batch of gels with batch number, expiry date, and
4.4.2 Regularly check and record shelf-life expiry dates to ensure timely rotation and disposal of expired products.
4.5 Handling and Storage Practices
4.5.1 Handle gels with care to prevent damage or contamination during storage.
4.5.2 Store gels away from incompatible materials, chemicals, or potential sources of contamination.
4.6 Documentation and Records
4.6.1 Maintain accurate records of storage conditions, temperature/humidity logs, and shelf-life monitoring.
4.6.2 Document any deviations from storage procedures and corrective actions taken.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Temperature and Humidity Logs
– Shelf-Life Monitoring Records
– Storage Area Maps and Designations
– SOP for Storage Conditions
7) Reference, if any
– ICH Q1A(R2): Stability Testing of New Drug Substances and Products
– FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
– Pharmacopoeial guidelines for storage of pharmaceuticals
8) SOP Version
Version 1.0