February 28, 2019 | FDA’s New Continuous Manufacturing Guidance Carries Process Validation Implications
In a new 27-page Guidance, ‘Quality Considerations for Continuous Manufacturing’, released February 27, 2019, the FDA and CDER (Center for…Read More
January 24, 2019 | FDA Release New Method Validation Guidance
Finalizing a draft guidance first issued in April 2016, the FDA have this week released a new final guidance for…Read More
December 20, 2018 | FDA Release New Data Integrity Guidance
Data Integrity remains a key focus for the FDA in 2018, now five years on since the subject was first…Read More
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