BRIEFING

 〈1110〉 Microbial Contamination Control Strategy Considerations. This new chapter proposal provides the main requirements and considerations for defining controls and assessing the effectiveness of the controls for microbial, endotoxin and/or pyrogen contamination sources in the manufacturing of pharmaceutical products. A contamination control strategy (CCS) should be implemented for the manufacturing of sterile products and is recommended for low bioburden and/or nonsterile product manufacturing.

 The companion chapter Microbial Contamination Control Strategies for Cell Therapy Products 〈1114〉 appears in this issue of PF.

 (GCM: H. Tu)

 Case ID—SUB-785