This research company had developed recombinant plants that expressed a beneficial protein (plus one or more marker proteins). Characterization and other studies were required to be submitted for marketing approval. These studies were supposed to be conducted under GLP, but no one in the company had experience with these regulations.
QAI was contracted to establish a GLP program to allow the company to conduct these studies under GLP. QAI followed the following steps:
Initially, all field and laboratory personnel, as well as all managers, were given training in the GLPs. This training included examples applicable to the work that was going to be performed in the studies.
A basic set of SOPs was prepared by customizing SOPs already in QAI’s collection. These included all the GLP required SOPs. Applicable forms relevant to these SOPs were also adapted from existing forms, and implemented.
The on-site new QA hire was trained by QAI on the application of GLP requirements to recombinant protein studies. This QA person used QAI for regular consulting during the entire course of the studies. Relevant data forms were developed by the on-site QA, with help from QAI.
After all studies had been completed and submitted, EPA inspected the facility for GLP compliance. A QAI consultant assisted the on-site QA with the inspection, and was present for the entire inspection. The inspector specified during the exit conference that there were no findings.