BLOOD PRODUCTS ADVISORY COMMITTEE MEETING
Issue Summary for Topic III: FDA’s Current Thinking on Product Standards, Quality Assurance, and Submission Requirements for Platelets, Pheresis
Issue: FDA intends to develop updated policies regarding product standards and quality assurance for apheresis platelets (Platelets, Pheresis). In order to define a regulatory policy that best addresses recent developments in the field, CBER seeks the advice of the Committee on FDA’s current thinking regarding donor selection, component collection, process validation, quality assurance testing, and standards for licensure applicable to apheresis platelets.
The practice of preparing platelets by apheresis using automated blood cell separators has expanded exponentially since publication of FDA’s current guidance “Revised Guideline for the Collection of Platelets, Pheresis – October 10, 1988.” However, since that time, many improvements have been made to the collection process, storage containers, and methods to determine platelet yields. In addition, apheresis collection procedures may now incorporate the collection of double and triple platelet components from a single procedure, the use of in-process leukocyte reduction, and the collection of concurrent plasma or Red Blood Cell components. CBER plans to update this guidance document to reflect new developments in the area of platelet component preparation. To address these issues, FDA will provide presentations on its current thinking, and an industry representative will discuss the complexities of plateletpheresis quality control in a large collection center, including related cost-benefit considerations.
It is important that platelet components should adhere to defined standards to ensure that their therapeutic value is characterized and predictable, and to minimize the overall number of donor exposures necessary to reach a therapeutic end point. In addition, CBER seeks to define and recommend an effective program for quality assurance monitoring of plateletpheresis components. FDA’s current thinking in these areas is as follows:
FDA seeks to establish a statistical framework for quality control strategies appropriate to address low volume production with a low rate of expected failures. FDA will discuss possible approaches involving product conformance within a defined confidence interval based upon binomial statistics, as well as a rate-ratio approach with pre-defined failure tolerance limits as they might apply to platelet apheresis quality control testing.
FDA’s current thinking regarding necessary elements of quality control for apheresis platelet components includes the following:
1. Does the Committee agree that the proposed recommendations for quality control testing are adequate to assure quality of Platelets, Pheresis?
2. If not, please comment on alternate approaches to quality control for Platelets, Pheresis.