Writing SOPs and Controlled Documents Explained: Best Practices for Regulatory Compliance How to Write SOPs and Controlled Documents for Regulatory Compliance: A Complete Guide Introduction to SOPs and Controlled Documents Standard Operating Procedures (SOPs) and controlled documents are foundational elements of pharmaceutical and biotechnology quality systems. They ensure processes are standardized, compliant, and auditable in alignment with regulations enforced by the FDA, the EMA, and the CDSCO. Poorly written or uncontrolled SOPs are a frequent cause of inspection findings and regulatory non-compliance. By 2025, agencies expect companies to implement globally harmonized SOPs, robust document control systems, and digital platforms (eQMS)…