HCT/P Environmental Monitoring Requirements

TP 42

The Food and Drug Administration (FDA) requires human cell, tissue, and cellular and tissue-based product
establishments to follow the current Good Tissue Practice (GTP), which governs the methods used in, and the
facilities and controls used for, the manufacture of human tissue and cellular and tissue-based products. The
following regulation is to be enforced as of May 25, 2005: 21 CFR 1271—Human Cells, Tissues, and Cellular and
Tissue-Based Products 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. The
excerpt from the regulation is …

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