Bioequivalence and Bioavailability Forum

❝ it is necessary to follow GMP during manufacturing finished dosage form for conducting pivotal BE studies.

• The test products used in the bioequivalence study must be prepared in accordance with GMP-regulations including Eudralex volume 4. (page 5)
  
• Packaging (including labelling) should be performed in accordance with good manufacturing practice, including Annex 13 to the EU guide to GMP. (page 7)
  
• Third country sites should be able to demonstrate standards equivalent to these GMP requirements compliant with local requirements. (page 8)

❝ do we need to manufacture the pilot batch too under GMP conditions for using in the pilot BE study?

❝ what are the guidelines recommends in this regards?

❝ do we need to manufacture the pilot batch too under GMP conditions for using in the pilot BE study?

1. If the pilot study turns out to be BE would you really risk getting into a situation where the study report couldn't be submitted as pivotal evidence?
   
2. What relevant info do you really get about your GMP product if you produce a non-GMP version of it and run a test?
   
3. Would you as a volunteer sign up for a study where one of the IMPs was non-GMP? OK, I know most volunteers don't know what that means in reality but I am talking about the principle here.
   
4. A few years back some sponsors were thinking along your lines and they did it very creatively in the US: They started using compounding as a means to get around GMP; for practical reasons GMP and compounding were never tightly connected, and there needed to be legal provisions for compounding in the US regulations. It is now a complete nogo under many or most circumstances. I shall not go into details about what the terms many or most mean in this context.