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Guidance for Industry Biological Product Deviation Reporting for Blood and Plasma Establishments GUIDANCE This guidance document is being distributed for comment purposes only. Comment sand suggestions
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What is biological product deviation?
Biological product deviation refers to any departure from the established standards or specifications for a biological product.
Who is required to file biological product deviation?
Manufacturers, packers, or distributors of biological products are required to file biological product deviation.
How to fill out biological product deviation?
Biological product deviation can be filled out by completing the appropriate form provided by the regulatory authority and submitting it with the required information.
What is the purpose of biological product deviation?
The purpose of biological product deviation is to ensure the reporting and investigation of any deviations from the established standards for biological products, in order to identify and address potential risks and maintain product quality.
What information must be reported on biological product deviation?
Biological product deviation reports must include information such as the product name, lot number, date of occurrence, description of the deviation, potential impact on product quality, and corrective actions taken.
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