Case Studies SOP Development

The Department of Pharmacology of this University had used the services of Quality Associates for Good Laboratory Practice Training (GLP)  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 of Pharmacology convinced them to use QAI for this implementation.  After an initial visit, QAI prepared a detailed gap analysis that identified, in particular, the need to develop a complete Laboratory Standard Operating Procedures Manual.  To this end, QAI used its boilerplate Standard Operating Procedures (SOPs) and customized them for the specific needs of the Department of Cardiology. After satisfying the majority of the standard Good Laboratory Procedures (GLP) requirements, QAI helped the Department of Cardiology develop the more technical SOPs that covered equipment and laboratory procedures used in this Department.  Forms associated with these SOPs were prepared by QAI to make clear and complete documentation easier during the performance of these procedures.  After SOPs and forms were implemented, QAI helped the Department of Cardiology again during the first revision cycle, providing editorial comments and improvement suggestions to upgrade these SOPs. The Medical Center  (GLP) Anatomy and Neurobiology Group and associated Department of Laboratory Animal Research of this University had started to establish a GLP program for nonclinical laboratory studies on non-human primates.  Quality Associates was selected to perform the routine function of Quality Assurance Unit.  An initial GLP audit by a commercial client identified a number of inadequacies in the GLP program as implemented.  Shortly after this audit, QAI followed up with its own gap analysis of the existing program.  Based on the results of the audit and gap analysis, QAI revised the entire SOP manual, editing most SOPs, and adding many other SOPs.  QAI used its boilerplate SOPs as the basis for these edits and additions.  One QAI employee is now identified as the QAU Manager, with one University employee as Quality Auditor for day-to-day audits.  Based on the improvements to the Quality System at the Medical Center, a commercial client has now awarded GLP nonclinical laboratory studies, which have now been initiated by the Department of Laboratory Animal Research.