Important Factors in Regulatory Compliance for Regenerative Medicine Products
Two Important Factors for Complying With Regenerative Medicine Regulations
Determining whether a donor is eligible or ineligible to donate cells or tissues for use in therapies.
- Based on donor screening and testing for communicable disease
- Requires thorough documentation
- Must screen for the list of diseases specified by FDA
- Donor eligibility is not required for autologous use
Good Tissue Practices
Emphasis on avoiding cross contamination and spread of communicable disease.
- Tracing of tissue from donor to recipient
- Distinct identification code for each donor to protect anonymity
- Methods to communicate potentially contaminated tissue to suppliers and recipients
- Ensure handling of HCT/P’s without mix-ups or cross contamination
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A Comparative Framework Between New Product and Legacy Product Process Validation
This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.