write-standard-operating-procedure

Create a GxP-compliant Standard Operating Procedure that provides clear, auditable instructions for regulated activities.

Expected: Every SOP has a unique ID following the organisation's document numbering convention. On failure: If no numbering convention exists, establish one before proceeding: [TYPE]-[DEPT]-[3-digit sequential].

Expected: Purpose is one to two sentences. Scope clearly defines boundaries. On failure: If scope overlaps with an existing SOP, either reference the existing SOP for the overlapping section or revise both SOPs to eliminate the overlap.

Write a GxP-compliant Standard Operating Procedure (SOP). Covers regulatory SOP template structure (purpose, scope, definitions, responsibilities, procedure, references, revision history), approval workflow design, periodic review scheduling, and operational procedures for system use. Use when a new validated system requires operational procedures, when existing informal procedures need formalisation, when an audit finding cites missing procedures, when a change control triggers SOP updates, or when periodic review identifies outdated procedural content. Source: pjt222/development-guides.