Current Good Manufacturing Practices (21CFR Part 211) require that raw materials, in-process materials, finished products, stability samples, and components are stored at the correct environmental conditions to maintain the integrity of the products and components.
To meet these requirements, temperature mappings of the areas and equipment used to store your products must be completed before they are used. The areas and equipment must also be remapped on a defined schedule so that you can rest assured that all of the areas and equipment used for storage are being maintained at the required environmental conditions.
If it is discovered during an audit that temperature mapping has not been completed and it is determined that your raw materials, in-process materials, finished products, and components are not being stored in the correct environmental conditions, your company could be exposed to FDA Form 483 observations, and even potential product recalls.
By using Mesa’s Compliance and Validation Services to complete the temperature mapping of your product storage areas and equipment you will know the environmental conditions in the areas or equipment, be able to determine the optimum storage locations for temperature sensitive products, and also select the best locations to place the Continuous Monitoring System sensors.
Trained Mesa Labs service technicians will place data loggers throughout your product storage locations, which will capture temperature and relative humidity readings, and provide a detailed map of the environmental conditions in your critical product storage areas. The mapping data will then be used to determine the locations of any cold or hots spots, and also the ideal locations for the placement of the Continuous Monitoring sensors so that you will be aware if the storage conditions go out of specification, and be able to prevent damage to your products and components.
By having Mesa Labs complete your temperature mappings of your product storage areas and equipment, you will:
- Know the locations of any hot and cold spots in your storage areas
- Have documented records of the environmental conditions of your product storage areas and equipment
- Be able to determine the optimum storage locations for temperature sensitive products
- Ensure that all requirements for the storage of your raw materials, in-process materials, finished products, stability samples, and components are meeting Current Good Manufacturing Practices (cGMP) requirements
Contact Mesa’s Compliance and Validation Services today, to find out how we can help you with your mapping needs.
Call us at 303.987.8000 or email us at email@example.com.
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