A Framework for Developing Global Standard Operating Procedures

Abstract

Since the late 1980s, pharmaceutical research and development units and contract research organizations have had to consider and adopt global operations to survive the demands of concurrent marketing authorization applications and shrinking monetary resources. Standardized procedures are vital for total quality in such global organizations but are often difficult to develop due to national, local, and cultural differences. Taking the ISO 9000 pyramid approach to the development of global procedures allows for a structural framework of standard operating procedures (SOPs) with the flexibility required to bridge differences by using a hierarchy of documents. Pharmaco LSR's approach starts with a common denominator or “gold standard,” which is the regulations and good scientific practices. This extends down to the second level, standard operating procedures, which provide common working instructions within the organization for compliance to good practices. The broadest tier of documents is the departmental procedures (DPs), which are developed by the various units in the organization to interpret and customize the SOPs that affect a particular geographic or functional work unit. The successful implementation of this globalization process in an organization involves leadership commitment, multiple brainstorming sessions, and dedicated teams with the will to succeed.