Validation SOP & Protocol Writing Competency Mastering SOP and Protocol Writing Skills for Pharma Validation Teams Introduction Validation SOPs and protocols are critical documents in pharmaceutical manufacturing. They define how validation is planned, executed, and documented to ensure compliance with current Good Manufacturing Practices (cGMP). Poorly written documents result in deviation, misinterpretation, and audit failures. Therefore, writing competency is a must-have skill for validation and quality professionals. This article offers a structured approach to improving SOP and protocol writing capabilities, aligning with FDA, EMA, WHO, and ICH expectations. We’ll cover writing styles, structure, formatting, common mistakes, and how to train…