Designing Validation Protocols: Scope, Tests, Acceptance Criteria & Documentation Best Practices Designing Validation Protocols in Pharma: Scope, Tests, Acceptance Criteria & Documentation Best Practices Validation protocols form the foundation of the pharmaceutical validation lifecycle. Whether for equipment qualification (IQ/OQ/PQ), cleaning validation, process validation, or utility system qualification, a well-structured protocol ensures regulatory compliance, test accuracy, and GMP traceability. This article offers a complete, step-by-step guide for designing robust validation protocols — focusing on scope definition, test strategy, acceptance criteria, documentation structure, and best practices aligned with FDA, EMA, and ICH expectations. 1. Importance of Protocols in Validation Validation protocols ensure…