FDA Guidance: Current Good Tissue Practice (GGTP) and Additional Requirements, 12/11

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The US FDA published this Guidance for Industry, titled Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to provide guidance on compliance with 21 CFR Part 1271, Current Good Tissue Practice.

Here are some of the topics specific to computers and software:

• Section V (Quality Programs) Part L provides guidance on computer system validation, verification, and documentation
• Section VII (Procedures) Part B allows for electronic (rather than physical) access to SOPs
• Section XVII (Storage) Part A gives an example of using a validated system to quarantine HCT/Ps
• Section XIX (Records) Part C provides guidance on backing up electronic records and discusses when you can and can’t destroy original paper records
• Section XVI (Label Controls) Part A allows for electronic (rather than hard copy) retention of electronic labels