FDA Q&A Guidance on the Implementation of a Pathogen Reduction System for Blood Products

Recommendation

9/10 May 2023
Heidelberg, Germany

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

In early November, the FDA published the final version of its Q&A guidance document on implementing a pathogen reduction system. With this document, the FDA aims to provide guidance to facilities that collect or process blood and blood components on the use of a specific pathogen reduction method for the production of pathogen-reduced blood components. Therefore, the FDA has collected specific questions from blood establishments that have chosen to use the INTERCEPT® Blood System for platelets and plasma and subsequently have questions about implementing this system to reduce pathogens. Based on this, the FDA has provided a Q&A guidance document that answers the most frequently asked questions. It also includes recommendations for approved manufacturers to report manufacturing changes related to the implementation of a pathogen reduction system under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).

The contents and recommendations of this document are intended for blood establishments that intend to manufacture pathogen-reduced platelet and plasma products using an FDA-approved pathogen reduction device. Currently, the INTERCEPT® Blood System is approved for the preparation of certain pathogen-reduced platelet and plasma products and for the preparation of cryoprecipitated fibrinogen complex. In the event of changes in product suitability or to the system itself, or if the FDA also approves another pathogen reduction device with a similar intended use in the future, it will consider further recommendations.

This paper is 13 pages long and contains the following sections:

I. Introduction
II. Questions and Answers

• A. General Information
• B. Manufacture of Pathogen-Reduced Blood Components by Blood Establishments 
• C. Reporting Implementation of Pathogen Reduction in Licensed Blood Establishments

III. REFERENCES
APPENDIX

This Q&A Guide finalises the draft guidance "Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers, Draft Guidance for Industry" of December 2017. For further details, please refer directly to the guidance "Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers".