Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) Environmental Monitoring Requirements


21 CFR 1271.195 Environmental control and monitoring Section 1271 requires facilities to establish and maintain procedures to adequately control and monitor environmental conditions and to provide proper conditions for operations.

The regulations were created to improve protection of the public health. Section 1271.195 specifies the monitoring parameters required, including:

  • Environmental control
  • Inspections
  • Environmental monitoring
  • Records

The paper includes specific recommendations for monitoring solutions to meet regulatory requirements. Other topics included in this paper:

  • 21 CFR 1271.195 requirements
  • Monitoring report frequency
  • ISO 5 classification overview

Interested in learning more? Complete the form on this page to receive a free copy of the HCT/P Environmental Monitoring Requirements application note.