Requalification and process validation in GMP

Описание к видео Requalification and process validation in GMP

🎓 Welcome back to the Scilife Academy! In this lesson, we’re exploring the critical concepts of Requalification and Process Validation in Good Manufacturing Practices (GMP).

💡 Gain insights from 40+ courses designed to enhance your skills in regulatory compliance and quality management. Start learning today: https://academy.scilife.io/app

In this video, you'll learn:
Requalification: Understand how to assess equipment and systems without repeating the full qualification process. Learn how to use risk scoring to determine periodicity and critical tests.
Process Validation: Discover how to establish documented evidence that manufacturing processes meet Quality requirements, exploring both traditional and continuous verification approaches.
Types of Process Validation: Gain clarity on prospective, concurrent, and retrospective validations, and understand their relevance under current FDA and EMA guidelines.
Continuous Process Verification: See how modern risk-based lifecycle approaches ensure consistent Quality control throughout a product's lifecycle.

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