Case Studies on Scientific Support

This Pharmaceutical Manufacturer is contracting most of the nonclinical bioanalytical phase of GLP studies at Contract Research Organizations (CRO).  Because of the number of studies involved, its study monitors, were not able to provide the attention required to the bioanalytical data and reports.  QAI was hired to provide this service.  One employee performed a scientific… Read more »

Case Studies SOP Development

The Department of Pharmacology of this University had used the services of Quality Associates for GLP training several years in a row.  When the Department of Cardiology of the same University decided that they needed to establish a GLP program for the safety studies they were planning with devices, the successful training in the Department… Read more »

Bioanalytical Support and Training

Performed an independent scientific review of the bioanalytical data and bioanalytical phase report of scores of animal studies for this pharmaceutical drug sponsor company.  The LC/MS bioanalyses had been performed at four separate laboratories.  The review was performed directly on the analytical electronic data acquired using Analyst, as well as on the documented work-up of… Read more »

GLP Training

QAI trainers have conducted several hundred GLP training seminars in numerous settings.  These included: Training in EPA GLP of one University Professor and four Researchers in his research laboratory to allow the conduct of three studies over a three-year period with the Professor as Study Director.  This multi-site study included other test sites, three of… Read more »

Standard Operating Procedures Development Case Study

This company had decided to conduct all product chemistry studies for physical and chemical properties of their pesticides in house. To implement this decision, the analytical laboratory had to be upgraded to abide by the GLPs. With several personnel in the laboratory familiar with the GLP requirements, the laboratory decided to contract QAI for the… Read more »

Support of Existing Quality Assurance Units Case Study

The size of the Registration Quality Assurance (RQA) unit of this pharmaceutical company provides all Quality Assurance requirement for the “steady-state” level of workload.  Occasionally, pivotal clinical studies are completed simultaneously just before submission for an IND or NDA.  Typically, the bioanalytical laboratory is required to analyze thousands of samples within a few weeks.  To… Read more »

Independent Quality Assurance Units Case Studies

Outsourcing of the QAU Function This analytical laboratory is a captive unit of a S&P 500 industrial manufacturer. Management prefers to outsource select operations, and contracted QAI to operate as the laboratory QAU, operating under EPA GLP, AIHA, and other state and federal requirements. A total of three full-time QAI employees operate as the QAU,… Read more »

Establishment of GLP Programs Case Study

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… Read more »