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FOOD AND DRUGS AUTHORITYREGULATORY FRAMEWORK FOR BLOOD, BLOOD COMPONENTS AND BLOOD PRODUCTSDocument No.: FDA/BPD/POL01 Effective Date: 2nd January 2019 Version No.:01BACKGROUND The legislative basis

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How to fill out biological product deviation reporting

01

Identify the biological product deviation that occurred.

02

Complete the appropriate reporting form with all necessary details.

03

Submit the completed form to the appropriate regulatory authorities within the specified timeframe.

Who needs biological product deviation reporting?

01

Biological product manufacturers

02

Biological product distributors

03

Healthcare providers

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What is biological product deviation reporting?

Biological product deviation reporting is the process of reporting any deviation or unexpected event that may occur during the manufacturing, testing, or distribution of a biological product.

Who is required to file biological product deviation reporting?

Manufacturers, distributors, and other entities involved in the production and distribution of biological products are required to file biological product deviation reporting.

How to fill out biological product deviation reporting?

Biological product deviation reporting can be filled out electronically through the FDA's electronic submission gateway.

What is the purpose of biological product deviation reporting?

The purpose of biological product deviation reporting is to ensure the safety, purity, and potency of biological products by promptly identifying and addressing any deviations in their production or distribution.

What information must be reported on biological product deviation reporting?

Information such as the nature of the deviation, the potential impact on the product, corrective actions taken, and any follow-up measures must be reported on biological product deviation reporting.

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