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.

编写符合 GxP 的标准操作程序 (SOP)。涵盖监管SOP模板结构（目的、范围、定义、职责、程序、参考文献、修订历史）、审批工作流程设计、定期审核安排以及系统使用的操作程序。当新的经过验证的系统需要操作程序时、现有的非正式程序需要正式化时、审计结果引用缺失的程序时、变更控制触发 SOP 更新时或定期审查发现过时的程序内容时使用。 来源：pjt222/development-guides。