Manufacturers of legacy products can take advantage of the knowledge gained from the original process development and qualification work to develop a pathway for validation.

May 7, 2025 · Learn how to implement rigorous process validation techniques in regulated industries. Process validation isn’t just about checking boxes for regulators—it’s about building …

Mar 18, 2025 · The process validation lifecycle is generally broken down into three distinct phases: Process Design, Process Qualification and Continued Process Verification. Each …

Jul 24, 2025 · This comprehensive guide provides you with a complete checklist and step-by-step approach to validate any process effectively. You’ll learn how to ensure consistent quality and …

Learn the essential steps of process validation to ensure quality and compliance in your organization.

Nov 11, 2025 · Learn about the stages, types, and examples of process validation, the guidance of FDA and GHTF for validating pharmaceutical manufacturing processes, and how to …

Learn the lifecycle approach to biotech process validation. This guide covers PPQ and CPV planning, execution, and monitoring based on FDA, EMA, and ICH guidanc

Jul 3, 2025 · What is process validation in pharma? Learn its definition, lifecycle stages, and GMP guidelines in this comprehensive guide for professionals and students.

Based on the GHTF (Global Harmonization Task Force) process validation guidance document 3. a process validation consists of three sequential elements: Each of these elements requires a …

Feb 19, 2025 · Need to improve your process documentation skills? Our process guide shows you how to write a process document, with examples and practical advice.