Tag: ICH Q8 Q9 Q10

Designing Pharmaceutical Processes for Validation Readiness

Designing Pharmaceutical Processes for Validation Readiness How to Design Pharmaceutical Processes for Stage 1 Validation Readiness Stage 1 of process validation—Process Design—lays the scientific and regulatory foundation for the entire pharmaceutical manufacturing lifecycle. It precedes process qualification and continued verification,…

Complete Guide to Process Validation in Pharmaceutical Manufacturing

Complete Guide to Process Validation in Pharmaceutical Manufacturing 1. Introduction to Process Validation Process validation is a critical and mandatory component of pharmaceutical manufacturing. It ensures that a manufacturing process consistently produces products that meet pre-established quality criteria. Defined by…