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Posts Tagged Biosimilars

EMA – Consultation on quality guideline for Biosimilars

EMA – Consultation on quality guideline for Biosimilars

The EMA has released a revised guideline on the quality requirements for Biosimilars, technology has moved on since the last guideline was issued in 2006 and the industry has a better understanding of the development, manufacturing and quality requirements for biosimilars. All QPs need an understanding of

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Latest QP Question

What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

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Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?


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