FDA finalizes new “Good Tissue Practice” rules
It’s estimated that more than one million human musculoskeletal transplants will be performed in 2005. This represents just part of the use of human cell, tissue and cellular and tissue-based products (HCT/Ps) to treat or cure a wide variety of conditions. The continued growth of the tissue industry has prompted FDA to publish three new rules to ensure the safety of HCT/Ps by establishing safety requirements to prevent contamination and the transmission of communicable diseases.
Microbiologist Kristen Hedgelon performs surface sampling in support of clients’ environmental monitoring programs.

The first rule became effective in 2001 and requires human tissue establishments to register with the FDA. Although Lancaster Laboratories does not actually process human tissue, laboratory testing is considered to be a phase of processing and, therefore, requires registration. Lancaster Labs recently amended its existing registration with FDA to include testing on HCT/Ps. This registration does not imply FDA approval, but it allows the agency to check the compliance of registered facilities through inspections. At a recent conference, FDA announced that 150 investigators will be trained this spring to inspect HCT/P facilities.

The most recent rule, entitled “Current Good Tissue Practices for Human Cell, Tissue and Cellular and Tissue-Based Establishments; Inspection and Enforcement,” (cGTP) is aimed at preventing the introduction, transmission and spread of communicable diseases. It becomes effective in May 2005, along with requirements for donor eligibility. Like other GXP regulations that are enforced by FDA, the cGTP regulations require a quality program with validated written procedures for the prevention of infectious disease and contamination during processing.

Lancaster Labs offers a variety of services to assist tissue processors in their compliance efforts, including validation of processes to document that they
consistently achieve acceptable results.

“We’ve worked with many clients on facility validation issues over the years,” says Mark Kaiser, director of pharmaceutical microbiology. “Our experience includes design and execution of environmental monitoring programs in manufacturing and processing facilities. We routinely collect and analyze air and surfaces samples to detect microbial contamination. And we support cleaning validation by testing samples from equipment and other surfaces to show that cleaning processes are effective in removing residual levels of cleaning agents or products.”

The new regulations do not require that HCT/Ps be processed in an aseptic manner, but any claims that a tissue processor’s methods reduce the risk of infection or contamination must be validated. Sterility testing of the final products is another of the many challenges of tissue processing. “We perform sterility testing using state-of-the-art isolator technology to reduce the risk of false positive results, which can occur when sterility tests are performed in a clean room,” explains Kaiser. He adds that the laboratories already have well documented procedures and validated processes in place because they routinely comply with current Good Manufacturing Practices and have been inspected by FDA.

For more information about the company’s analytical testing services for HCT/Ps, please contact Pharmaceutical Business Development at (717) 656-2300 or e-mail pha@lancasterlabs.com.