Operationalization of Research SOPs for PhD Scholars

Standard Operating Procedures (SOPs) are a set of detailed written instructions that are followed to complete the prerequisite tasks in an orderly fashion. The aim of an SOP is to obtain consistent results, which comply with Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). In academic organizations, SOPs have been given less importance primarily due to evolutionary nature of protocols. Standardized procedures are written in workbooks or Journals and never recorded as an SOP. Moreover, research guides are not from the pharmaceutical industry thus, they often lack exposure to Quality concepts which is mandatory in a regulated industry. Finally, academic institutes are not highly regulated as they are considered to be the centers of excellence and are mainly non-clinical, and have not completely transitioned into the clinical setup. Research on developmental issues in the Pharmaceutical industries are carried out in R&D units. However, operating procedures in the laboratory are a part of the Quality Management System of the US FDA Code of Federal Regulations (CFR), Title 21, and other guidelines governed by the International Standards Organization (ISO), especially 9001. This chapter aims to introduce the concept of operationalization of SOPs in a PhD training program as we transition from research to a clinical environment. This is a prerequisite for future commercialization while meeting all the regulatory compliances. SOPs are now being incorporated into the system to ensure a risk-averse procedure, which is a part of the quality system, thus ensuring consistency of protocols to ascertain reliable results that form the basis of future diagnosis and treatment.