Standard Operating Procedures

Standard Operating Procedures (SOP's) are pervasive in the pharmaceutical industry. For example, a single mechanical piece of equipment may have the following SOP's.

  • Preventive Maintenance
  • Operational Maintenance
  • Operating Procedure(s)
  • Data removal and backup
  • Validation Procedure(s)
  • Cleaning
  • Storage
  • Set-Up

Other "equipment" that requires SOP's may be less obvious such as clean rooms, HVAC systems, security and alarms, chillers, house vacuums, back-up power systems, and on and on. QPS writes SOP's for processes and equipment. P&ID's are commonly supplied by the original verndor or builder for equipment, and often, they are never again revisited. Changes occur, and must be controlled.