Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) are detailed, written instructions that describe standardized processes and practices to ensure consistency and compliance.

SOPs are controlled documents within a Quality Management System (QMS) and undergo a structured document lifecycle. They are developed by qualified personnel for specific processes defining purpose, scope, responsibilities and process workflows. They must be regularly reviewed and updated to reflect process changes, improvements, or regulatory updates. A revision history is maintained for traceability.

Training of SOPs is mandatory for personnel in the GxP-field based on their conducted activities and responsibilities. Deviations from SOPs need to be documented and assessed. A deviation may result in corrective and preventive actions (CAPA) depending on its nature. Outdated documents need to be archived based on regulatory requirements. When the retention period expires, controlled documents are securely disposed.