Developing a Sample Tracking System for an FDA Regulated Process in a cGMP Manufacturing Facility

Abstract

Cytoimmune Therapeutics was looking for a sample tracking form for their new biomedical treatment. The company budget was considered, and an affordable custody form system was developed to record data following FDA guidelines and biomedical samples specifications. This form was adjusted to be implemented in a cGMP manufacturing facility. The tools selected for the sample tracking system were Microsoft Word for the software and barcodes for the identification system for their affordability and applicability. The sample tracking system was tested and received positive feedback from both teams (laboratory and manufacturing teams), principally the manufacturing team who are responsible for providing the recorded information to the FDA. Key Terms ⎯ barcode, biomedical cancer treatment, custody chain.