Establishment of Good Laboratory Practice (GLP) Programs
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 Good Laboratory Practices (GLP), but no one in the company had experience with these laboratory regulations.
Quality Assurance Consultancy was contracted to establish a GLP program to allow the company to conduct these studies under GLP. Our experts 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 Standard Operating Procedures (SOPs) was prepared by customizing SOPs already in our 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 quality assurance (QA) hire was trained by our experts on the application of GLP requirements to recombinant protein studies. This QA person used Quality Assurance Consultancy for regular counsel during the entire course of the studies.
- Relevant data forms were developed by the on-site QA, with help from us. After all studies had been completed and submitted, the U.S. Environmental Protection Agency (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 negative findings.