Standard Operating Procedure for Storage Conditions of Creams
1) Purpose
The purpose of this SOP is to outline the procedures for proper storage conditions of creams in a pharmaceutical manufacturing facility to maintain product stability and integrity.
2) Scope
This SOP applies to all personnel involved in the storage of creams within the pharmaceutical production facility. It covers procedures for storage area requirements, temperature monitoring, and handling practices.
3) Responsibilities
It is the responsibility of the warehouse and quality control (QC) teams to follow this SOP accurately. The warehouse manager is responsible for ensuring that creams are stored under appropriate conditions, while the QC team monitors storage conditions to ensure compliance with regulatory requirements.
4) Procedure
4.1 Storage Area Requirements
4.1.1 Ensure that the storage area for creams is clean, dry, and well-ventilated.
4.1.2 Implement a dedicated storage area with adequate shelving or racks for organized storage.
4.1.3 Label storage shelves or racks with product name, batch number, and expiry date.
4.2 Temperature and Humidity Monitoring
4.2.1 Monitor and record temperature and humidity levels in the cream storage area regularly using calibrated monitoring devices.
4.2.2 Ensure that temperature is maintained within the specified range as per product requirements (e.g., 15-25°C).
4.2.3 Take corrective actions if temperature or humidity deviates from acceptable limits and document these actions.
4.3 Handling Practices
4.3.1 Handle creams with care to avoid damage to packaging and containers.
4.3.2 Rotate stock using a first-in, first-out (FIFO) principle to minimize expiry risks.
4.3.3 Avoid exposing creams to direct sunlight, heat sources, or moisture during storage.
4.4 Security and Access Control
4.4.1 Restrict access to the cream storage area to authorized personnel only.
4.4.2 Implement security measures to prevent unauthorized access and theft.
4.4.3 Maintain a logbook for entry and exit of personnel accessing the storage area.
4.5 Storage Records and Documentation
4.5.1 Maintain accurate records of cream inventory, including receipt, storage, and distribution.
4.5.2 Document temperature and humidity monitoring records, deviations, and corrective actions taken.
4.5.3 Archive storage records as per the document retention policy.
5) Abbreviations, if any
QC: Quality Control
FIFO: First-In, First-Out
6) Documents, if any
Temperature and Humidity Monitoring Records
Inventory Management Records
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
USP (United States Pharmacopeia) General Chapter 1079: Good Storage and Shipping Practices
8) SOP Version
Version 1.0
