EMA annex 15 – Pharma Validation

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,…

Managing Revalidation & Change Control in Pharma: Ensuring Ongoing Compliance Through Lifecycle Updates

Managing Revalidation & Change Control in Pharma: Ensuring Ongoing Compliance Through Lifecycle Updates Managing Revalidation & Change Control in Pharma: Ensuring Ongoing Compliance Through Lifecycle Updates 1. Introduction: Why Revalidation and Change Control Are Crucial Pharmaceutical validation is not a…

Equipment Qualification in Pharma: Complete Guide to IQ, OQ, PQ & DQ

Equipment Qualification in Pharma: Complete Guide to IQ, OQ, PQ & DQ How to Qualify Equipment in Pharma: Full Guide to IQ, OQ, PQ & DQ 1. Introduction to Equipment Qualification Equipment Qualification (EQ) is a critical aspect of Good…

Complete Guide to Cleaning Validation in Pharmaceutical Manufacturing

Complete Guide to Cleaning Validation in Pharmaceutical Manufacturing Everything You Need to Know About Cleaning Validation in Pharma 1. Introduction to Cleaning Validation Cleaning validation is a cornerstone of GMP compliance in pharmaceutical manufacturing, designed to ensure that equipment used…

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…