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.

編寫符合 GxP 的標準作業程序 (SOP)。涵蓋監管SOP模板結構（目的、範圍、定義、職責、程序、參考文獻、修訂歷史）、審核工作流程設計、定期審核安排以及系統使用的操作程序。當新的經過驗證的系統需要操作程序時、現有的非正式程序需要正式化時、審計結果引用缺失的程序時、變更控制觸發 SOP 更新時或定期審查發現過時的程序內容時使用。 來源：pjt222/development-guides。