Government Regulation
The health care industry is one of the most highly regulated industries in the United States. The federal government, individual state and local governments, as well as private accreditation organizations oversee and monitor the activities of individuals and businesses engaged in the development, manufacture and delivery of health care products and services. Federal laws and regulations seek to protect the health, safety and welfare of the citizens of the United States as well as prevent fraud and abuse associated with the purchase of health care products and services with federal monies. The relevant state and local laws and regulations similarly seek to protect the health, safety and welfare of the states' citizens. Accreditation organizations compile and support industry standards as well as monitor new developments. The following is a general description of the current laws and regulations, as well as the status of relevant developing laws to which the field may be subject.

FDA Regulation of Cell Therapy Facilities
Since December 1993, the FDA has been considering appropriate guidelines and a regulatory pathway to regulate the development, manufacture and distribution of somatic cell therapy products. The cGMP guidelines of the FDA embody a set of principles or a system of values that govern every aspect of laboratory operations. These guidelines are designed to ensure that the processes and/or products resulting from such operations meet defined safety requirements and have the identity, strength, quality and purity characteristics as those represented to the FDA. Currently, facilities and systems used for the manufacture, processing, testing, handling, packaging and distribution of cell therapy products must be cGMP compliant. In addition, the FDA recently brought in sweeping regulation mandating that any procedure in which human cells will be manipulated for clinical use will be subject to federal manufacturing standards and oversight. Specifically, Part 1271 of Chapter 21 of the Code of Federal Register unifies the registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P"s) and to establish donor-suitability, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's. These regulations, known as the Good Tissue Practice (GTP) requirements, encompass the minimal manipulation of cells for clinical use; i.e. for processes that do not alter the biologic characteristics of the cells. The institution of these regulations obligates the manufacturer to perform these procedures in FDA-registered facilities operating with the appropriate personnel, procedures and systems to meet with this enhanced level of regulatory scrutiny. The regulations are intended to 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 or mixed-up during manufacturing. For procedures in which the biologic nature of the cells is altered to affect a clinical outcome, termed "more than minimal manipulation,” Part 211 pharmaceutical cGMP will apply, as well as relevant aspects of Parts 210, 600 and 1271, additional FDA provisions for manufacturing establishments

Key elements of the cGTPrule are:

• Establishment of a quality program, which evaluates all aspects of the facility"s operations, to ensure compliance with GTP;
• Establishment of systems to determine and document donor eligibility
• 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; and
• Procedures for tracking the product from donor to recipient, and from recipient to donor.

PCT designed its facilities and systems in anticipation of these proposed rules and in compliance with existing rules, laws and guidance.

For a useful consoldiation of references recentl published by the Office of Cellular, Tissue and Gene Therapies of the FDA Center for Biologics Evaluation and Research, see:

References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)
Posted: 4/27/2006
http://www.fda.gov/cber/genadmin/octgtprocess.htm