Tag Archive: regulations

Annex 21 – Are we on track and is there an impact?

April 26, 2024 || Geraldine Carr-Mulry
 
Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements specified in this guideline and to consider whether this guideline has helped manufacturers, healthcare providers, and patients.  So, what is Annex 21? Annex 21 details the GMP…
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Translating Study Reports – A GLP Draft Guidance

April 26, 2024 || LeAnna Pearson
 
Introduction: In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil, China, India, and Japan.  The final test reports and accompanying documentation require translation from the facility’s native language to English when performing the testing.  All…
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