21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
For specific questions please contact Mark Hallworth at mhallworth@pmeasuring.com or 303.443.7100.
Papers
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The 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 21 CFR Part 1271 regulation was enforced as of May 25, 2005... Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Counters for Pharmaceutical Cleanrooms (381.5 KB) This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to... Download above file for full tables and figures, or for overview, see HTML Version. |
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