Standard Operating Procedure (SOP) Development

The Department of Pharmacology of this University had used the services of Quality Assurance Consultancy for Good Laboratory Practices (GLP) Training for several consecutive years. 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 our experts for this implementation.

After an initial visit, we prepared a detailed gap analysis that identified the need to develop a complete laboratory standard operating procedures (SOP) manual. To this end, we used its boilerplate SOPs and customized them for the specific needs of the Department of Cardiology. After satisfying the standard GLP requirements, Quality Assurance Consultancy 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 our experts to make clear and complete documentation easier during the performance of these procedures.

After SOPs and forms were implemented, we advised the Department of Cardiology again during the first revision cycle, providing editorial comments and improvement suggestions to upgrade these SOPs.

Additionally, 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. We were selected to perform the routine function of quality assurance unit (QAU). An initial GLP audit by a commercial client identified several inadequacies in the GLP program as implemented. Shortly after this audit, we followed up with our own gap analysis of the existing program. Based on the results of the audit and gap analysis, we revised the entire SOP manual, editing most SOPs and adding many other SOPs. Quality Assurance Consultancy used its boilerplate SOPs as the basis for these edits and additions. One of our specialists 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 were initiated by the Department of Laboratory Animal Research.