Huxsoll, Jean F. (1990, ASQC) Hana Biologics, Inc., Alameda, CA
Clinical development of any drug or device necessitates the corresponding development of appropriate quality systems. After a method was developed for processing human pancreatic cells for transplantation into humans to treat diabetes, the company undertook clinical studies to show the safety and efficacy of the material. This presentation will show how we developed and implemented the necessary quality assurance systems as we developed the product and initiated our clinical studies.
We first established company quality commitments related to the safety of the product, and 21 CFR GMP drug and device requirements. The next major effort was to develop a documentation system to allow traceability and facilitate product reproducibility that was both practical and timely. The documentation system incorporated the quality principles; test methodologies for raw materials, in-process materials and final product; raw material receipt; manufacturing processes and release specifications systems that had been developed. The systems established included quality assurance in the approval cycle for product specifications, labeling and manufacturing methods.
A vendor approval and audit system was initiated that included suppliers of components and raw materials as well as testing laboratories. Validation was undertaken to show test sterile fill operations. An internal audit system was developed.
Systems were set up for dispositioning non-conforming materials. A method of trend analysis was developed. Internal training programs were established for both operators.
The success and failures that occurred during this quality system developmental work will be shared with recommendations from our experiences.