FDA publishes Questions and Answers on Pathogen Reduction in Blood Components

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

The reduction of pathogens and the appropriate technologies are a frequently discussed topic in the area of extracting and manufacturing blood products and blood components. In December 2017, the FDA published a guideline with questions and answers on this issue for comments. This "Draft Guidance for Industry: Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers" contains the FDA's recommendations on the implementation of technologies and systems for the reduction of pathogens in blood components. They're addressed to establishments involved in the donation and processing of blood and blood components. The document includes additionally  recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of pathogen reduction under 21 CFR 601.12.

The present document summarises the most frequently asked questions and their answers. It also includes information for licensed manufacturers in case of a change in the manufacturing process related to pathogen reduction as per CFR 601.12.

The draft's focus lies on manufacturers of platelets and plasma products who work with the pathogen reduction procedure approved by the FDA. Currently, the FDA's "Incept Blood System" is approved for this purpose. The guideline now answers frequent questions, such as which blood components can be processed with this procedure, to what extend does the system make further tests unnecessary or to what extend other comparable systems may be used, as well.

Read up on all current questions and answers directly in the draft guideline "Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers".