BRIEFING

 〈1114〉 Microbial Contamination Control Strategies for Cell Therapy Products. This new chapter proposal is based on the version published in PF 48(5). The previous proposal has been canceled and is being replaced by this updated version, which includes the following revisions by the Microbiology Expert Committee.

1. The main requirements and considerations for defining controls and assessing the effectiveness of the controls for microbial, endotoxin and/or pyrogen, and particle contamination sources in the manufacturing of pharmaceutical products has been moved to the companion chapter Microbial Contamination Control Strategy Considerations 〈1110〉.

2. This chapter provides additional contamination control strategy (CCS) considerations specific to the manufacturing of cell therapy products.

The companion chapter 〈1110〉 also appears elsewhere in this issue of PF.

 (GCM: H. Tu)

 Case ID—SUB-784