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Good Tissue Practices
Is Your Organization GTP Compliant?
The United States Food and Drug Administration has issued its final rule on Good Tissue Practice (GTP), entitled, "Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement." The rule became effective May 25, 2005. The Good Tissue Practice rule regulates the methods, facilities and controls used in manufacturing these products.
The purpose of the Good Tissue Practice rule is for establishments that manufacture human cell, tissue, and cellular and tissue-based products (HCT/Ps). The FDA believes that, together with establishment registration, HCT/P listing, donor screening and donor testing requirements, requirements for current good tissue practice will increase the safety of HCT/Ps, and public confidence in their safety, by preventing the introduction, transmission and spread of communicable disease. The Agency's actions are intended to improve protection of the public health while minimizing regulatory burden. In addition, GTP regulations will help ensure that donors of human cellular and tissue-based products are free of communicable diseases, and that the cells and tissues are not contaminated during manufacturing and maintain their integrity and function. Key elements of the proposed rule are:
- Establishment of a quality program, which would evaluate all aspects of the firm's operations, to ensure compliance with GTP
- Maintenance of an adequate organizational structure and sufficient personnel
- Establishment of standard operating procedures for all significant steps in manufacturing
- Maintenance of facilities, equipment and the environment
- Control and validation of manufacturing processes
- Provisions for adequate and appropriate storage
- Record keeping and management
- Maintenance of a complaint file
- Procedures for tracking the product from donor to recipient, and from recipient to donor
- Validation Plus can help you meet and exceed Sustainable Compliance Standards
If your organization is currently reviewing the best way to approach any of the key elements for the new GTP regulations, Validation Plus can assist you in the transition to meet and exceed the new "sustainable compliance" standards for GTP.
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