EMA Guideline Guideline on the use of bovine serum in the manufacture of human biological medicinal products

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

On 1 December 2013, the adopted Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect. This document, adopted on 30 May 2013 by the Committee for Medicinal Products for Human Use, replaces the Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02).

This guideline outlines the general principles that should be applied to the control of the quality and safety of bovine serum used during the manufacture of human biological medicinal products. The original guideline (CPMP/BWP/1793/02) was adopted by CPMP in July 2003 and came into operation in October 2003. This revision affects mainly Sections 7.3.3 and 7.3.4 where the testing requirements for BVDV and anti-BVDV antibodies have been revised to be in accordance with the requirements applied for the production of immunological veterinary medicinal products (EMEA/CVMP/743/00-rev 2.).

Recommendations included in this guideline can also be taken into consideration when bovine serum is used in the control of a medicinal product, since the quality of the serum included in the nutritive media for cells within a quality control procedure can play a major role in the reliability of the results obtained.

Testings, such as Virals Saftey Testing or others, can be outsourced and done by  the serum supplier,  the medicinal product manufacturer (serum user), or to a contract laboratory, but this guideline is not intended to define who should do it. It defines the testing which should be performed. The resonsibility for the required standard testing is located at the marketing authorisation applicant. Furthermore compliance with the TSE Note for Guidance must be demonstrated.

For more detailed information please see the complete Guideline entitled "Guideline on the use of bovine serum in the manufacture of human biological medicinal products".