A comprehensive SOP system is required for manufacturers in the regulated pharmaceutical and medical products industries. Many non-regulated manufacturers in other industries do not have experience with a comprehensive SOP documentation system. SOPs provide a mechanism for controlling the activities within an organization to achieve consistency and uniformity. This is accomplished by outlining standardized, written work instructions for tasks. Among the many benefits of an established SOP system are:

• Reductions in human errors.
• Structured training programs.
• Consistent communication and comprehension of job tasks.
• Greater ability to determine root causes of process deviations.

Most organizations establish a formal documentation system for controlling and maintaining their SOPs. An identification system is defined so that SOP groups can be established pertaining to overall organizational management (global SOPs that apply to the entire organization) and individual departmental management (SOPs that are only pertinent to the activities performed by specific personnel). A highly regulated business will require SOPs for controlling the performance of all routine tasks as well as unplanned activities. A non-regulated business may only need to implement SOPs for controlling their most critical functions for ensuring production process consistency and quality control.

SOP content typically includes:

• Unique identifying document number.
• Descriptive title.
• Scope statement.
• SOP change history log.
• Work instruction task outline and/or checklist.
• Materials and equipment list.
• Responsibility assignments by department or job function.
• Cross reference for impact with other SOPs.
• Management approval.

Changes to SOPs are often controlled via a documentation change control process (which itself is defined by an SOP). Personnel training can be mandated to the extent that personnel may not be permitted to perform the tasks outlined in an SOP until they have received the proper training. Additionally, the establishment of a standardized training program for an entire organization may be defined by SOP.