Welcome to 1271 Quality. We Provide GTP Quality Assurance Solutions to Human Tissue and Cellular Therapeutics Firms.

Call today for a one hour initial consultation on any topic gratis, you will leave impressed!

Our quality assurance consultancy works to ensure a human tissue or cellular product establishment conforms to good tissue practice regulations (21 CFR Part 1271, the GTPs) and makes improvements to meet the requirements. We are a fresh, independent perspective from which to view your firm’s GTP position and to determine the efficacy of your quality systems. Our primary mission is ensuring patient safety related to tissue intended for transplantation while promoting the generous act of donation. Our services (view list) and our innovative 1271 Solutions Toolkit (© 2005 IMIT Consulting, LLC) combine to speed a firm towards satisfying FDA enforced regulatory requirements.

We focus on a quality program's effectiveness in meeting the core-GTP requirements. Specifically, we improve the procedures and documentation related to donor eligibility determination, recovery, processing, packaging, labeling, storage and distribution of tissue products. We have tissue experience in: (1) conducting GTP audits at tissue and eye banks, (2) developing standard operating procedures that meet regulatory requirements, (3) qualifying equipment such as cleanrooms, BSCs and refrigerators, (4) validating processes for tissue processing and sterilization of reuseable medical instruments, (5) validating/verifying software, (6) establishing an environmental monitoring program, and (7) supporting FDA Investigations and responding appropriately to 483 observations.

We recommend tissue establishments engage IMIT Consulting to conduct a GTP compliance audit of all or a selected part of your operations. Based on audit results we'll develop a plan that proactively responds to potential observations before your FDA inspector can find them. This plan when approved provides safe harbor in which to develop a compliant quality program.

The FDA has taken enforcement action against firms engaged in donor eligibility determination, processing and distribution of human tissue intended for transplantation. It appears this enforcement activity is expanding. Our quality assurance products and methodology are designed specifically for tissue establishments. Please review our products by which to prepare your establishment for FDA inspections in this new era of GTPs. Thanks for your interest. We look forward to working with you.

— Robert Carrier, Principal Consultant and Founder



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