balvanth
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India,
2012-07-09 15:33
(4280 d 23:33 ago)

(edited by Jaime_R on 2012-07-17 15:00)
Posting: # 8909
Views: 10,935
 

 Pilot BE Study [GxP / QC / QA]

Dear All,

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

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?

Regards
BKumar
QA, GPR


Edit: Catgory changed. [Jaime]
Helmut
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Vienna, Austria,
2012-07-09 18:01
(4280 d 21:05 ago)

@ balvanth
Posting: # 8912
Views: 9,983
 

 Pilot BE Study (GMP requirement)

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 CVintra – which can be totally different from a GMP-compliant production batch.

❝ what are the guidelines recommends in this regards?


See above.

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balvanth
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India,
2012-07-17 16:01
(4272 d 23:05 ago)

@ Helmut
Posting: # 8951
Views: 9,658
 

 Pilot BE Study (GMP requirement)

Thank you for your inputs...

can we manufacture pilot batch in r&d setup and use for pilot BE study to see or get some kind of understanding????


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]
Ohlbe
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France,
2012-07-17 16:49
(4272 d 22:17 ago)

@ balvanth
Posting: # 8952
Views: 9,743
 

 Pilot BE Study (GMP requirement)

Dear Balvanth,

According to ICH GCP, § 5.13.1:
The sponsor should ensure that the investigational product(s) [...] is manufactured in accordance with any applicable GMP [...].

My interpretation would be that manufacturing the batch in a non-GMP environment would not be acceptable.

Regards
Ohlbe

Regards
Ohlbe
ElMaestro
★★★

Denmark,
2012-07-17 19:56
(4272 d 19:10 ago)

@ balvanth
Posting: # 8953
Views: 9,670
 

 Pilot BE Study

Hello balvanth,

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


Further to the answers above:
  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.

Pass or fail!
ElMaestro
Jay
☆    

India,
2013-11-22 09:33
(3780 d 04:33 ago)

@ ElMaestro
Posting: # 11942
Views: 8,403
 

 Pilot BE Report

Dear all,

Regarding Pilot Study do we require to generate the clinical study report in ICH E3 format or for Pilot Study short summarised report is sufficient.

As if regulatory EU or USFDA asks for report one have to provide the same.

Regards,
Jay
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