Bioequivalence and Bioavailability Forum

Dear BKumar!

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

Yes. See EMA’s GL (2010):

• 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?

Not sure what you mean here. Are you referring to a kind of ‘experimental’ (lab-size) batch before upscaling? I would not do that. One rationale of a pilot study is to get estimates of the T/R-ratio and the CV_intra – which can be totally different from a GMP-compliant production batch.

❝ what are the guidelines recommends in this regards?

See above.