Information on SOP writing

About this video

• Video Title: Information on SOP writing
• Channel: ScreamBiscuit
• Speakers: Not specified in the transcript
• Duration: 00:05:21

Overview

This video provides a comprehensive guide on writing Standard Operating Procedures (SOPs) and other procedural documents. It explains the distinction between SOPs and work instructions, outlines the steps involved in writing an SOP, and offers additional considerations for both authors and managers of these documents to ensure GCP compliance and efficient process management.

Key takeaways

• Types of Documents for GCP Compliance: Two main types of documents are used: Instructions (like SOPs and work instructions) that guide processes, and Records that provide evidence of adherence to those instructions.
• SOP vs. Work Instruction: SOPs provide broad, detailed written instructions for achieving uniformity in specific functions, while work instructions offer more detailed guidance on how to perform a particular task within an SOP, often in the form of process flows.
• Steps to Write an SOP: Key steps include mapping the process end-to-end, identifying stakeholders and their responsibilities, identifying and addressing gaps or non-compliance areas, defining necessary records, and outlining clear tasks and responsibilities within the SOP.
• Elements of an SOP: An SOP should cover its purpose and scope, outline clear tasks and responsibilities, and may refer to work instructions for more detailed task execution.
• Document Management: Procedural documents require a clear numbering and version control system, a defined document owner, a review and approval process involving stakeholders, and a lifecycle management plan including regular review, updates, and archiving of obsolete documents.
• Additional Tips for SOP Authors: Procedural documents should be concise, use clear titles and unambiguous language, avoid jargon, maintain a logical flow, and assign responsibilities clearly to single stakeholders within the organization.