QPQuandary
Call QPQuandary on: 07813 677741

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

Read more

Latest QP Question

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

Latest QP Scenario Practice

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?

Testimonials

"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.

Read More...

Contact Information

20 Playfield Close, Biggleswade, Bedfordshire, SG18 8JL
Phone: 07813 677741
Website: http://www.qpquandary.co.uk
Email: alex@qpquandary.com"